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Summary:

The VP of New Business Development manages the business development function across all sites, ensuring that the business development function adequately supports the company in meeting site specific and company-wide goals.

The VP of New Business Development approaches their role from a results-driven and goal-oriented perspective, approaching their tasks with energy and an innovative mindset to ensure that Segal Trials’ study pipeline supports the company’s mission and goals.

The individual in this position creates and manages all business development operations as needed and works closely with other Segal Trials’ management teams to ensure enterprise success. This individual also sees to it that all prospective sponsors and clients are handled with the highest level of customer service and professionalism, and that quotas for future trials are met or exceeded.

This position may be In-Person, Remote or Hybrid

Summary of Essential Job Functions:

• Identify and secure new business opportunities for Segal Trials by developing and maintaining study leads and client relationships.
• Attend targeted therapeutic conferences and exhibitions and represent the company by exhibiting professionalism, excellent communication, and a deep knowledge of the company’s abilities.
• Develop new business proposals for Segal Trials and submit to relevant sponsoring pharmaceutical companies and Contract Research Organizations (CROs).
• Mine Pharmaceutical and Biotech company pipelines for potential new business opportunities.
• Oversee the completion of study feasibility forms for all Segal Trials investigators.
• Identify potential study opportunities, considering enrollment timelines, competing trials, access to patient population, and other factors, along with other company management teams.
• Oversee the negotiation of contracts and change orders with CROs and sponsoring pharmaceutical companies.
• Attend company Site Selection Visits (SSVs), providing study and other relevant details to attendees prior to the visit, and following up after the visit, as needed.
• Develop relationships and contract terms with new vendors, as needed.
• Maintain a comprehensive knowledge base of Segal Trials’ current and past study performance in enrollment and data quality in order to communicate effectively with clients.
• Maintain a consistent knowledge base regarding Segal Trials’ current and past capabilities, including, but not limited to, indications, phases, and types of investigational products in order to communicate effectively with clients and prospective clients.
• Ensure that the Clinical Trials Management System (CTMS) is accurately updated with new studies that are upcoming in the pipeline and ensure all ongoing studies are accurate at all times.
• Maintain a database of information regarding sponsoring pharmaceutical companies and CROs and their pipeline of upcoming studies, as well as relevant business development contacts.

Report Analysis and Oversight:

The VP of New Business Development is responsible for the oversight of the responsibilities and reporting procedures allocated to the Study Start-Up Specialist. The areas of oversight include:

• A consistently updated list of budget items and justifications for use in budgeting and contracting with sponsors and CROs.
• A consistently update a list of Segal Trials’ Physician Investigators and their trial history.
• Maintenance of the pipeline report with trials in all stages of business development and provide to executive leadership and management team members regularly as directed.
• Reviewing potential new business opportunities, obtain updates from client contacts, and report findings to executive leadership and management team members regularly as directed.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

Skills And Qualifications:

• 3 years previous experience in clinical research required.
• Previous Sales or business development skills required (Does not have to be healthcare related).
• Proficiency in English required.
• Proficiency with Microsoft Office, including Outlook and Excel.
• Familiarity with a CRM application required.

Education:

• Bachelor’s Degree preferred.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Business Development Coordinator is responsible for the administrative responsibilities associated within the business development department, including new study leads and the management of data and metrics. Coordinator handles completion of CDAs across all sites, ensuring timely study start up and support of the company’s site specific and company-wide goals. The Coordinator approaches their role from a results-driven and goal-oriented perspective, approaching their tasks with energy and a collaborative mindset. The individual in this position works closely with other Segal Trials departments to ensure enterprise success in compliance with study and non-study regulations but not limited to the study protocol, HIPAA, OSHA, GCP, GDP, CRF, ICH Guidelines and site Standard Operating Procedures (SOPs) and Work Instructions (WIs). Business Development Coordinator ensures that all prospective sponsors and clients are handled with the highest level of customer service and professionalism.

DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Familiarize self with Segal Trials research sites, historical performance, capabilities, mission, and vision to represent the company with the utmost professionalism.
• Handle the timely execution and submission of CDAs (within 1 business day of receipt) and assess if all of company’s investigators have been provided with the potential trial opportunity.
• Handle the timely execution and submission of Feasibility Questionnaires (within 3 business days of receipt).
• Handle the accurate and timely completion of all business development technology systems (CTMS, Devana, etc.) related to study progress milestones, study contact information, and uploading of appropriate documents.
• Maintain and regularly update PI Performance metrics (# studies by indication, investigator experience) within business development collateral.
• Maintain and regularly update the site network forecast report (enrollment periods per site)
• Attend SSV/PSSVs for all site network departments and gather accurate enrollment timelines, enrollment expectations and site selection information.
• Update the CVs of Principal Investigators, Sub-Investigators, Raters, Coordinators, Research Assistants, and Contractors with new studies awarded and completed, authorships, seminars, posters, abstracts, awards, and licensures.
• Update internal site reports with current studies, upcoming awarded studies, and new studies in each site’s pipeline and ensure all study metrics are maintained with accuracy using the business development technology systems.
• Create and maintain collateral to be used in business development functions, with special attention to FDA Approved Medications, Site Profiles, Staff Biographies.
• Attend and facilitate meetings with relevant sponsoring pharmaceutical companies and Contract Research Organizations, such as preferred partnership meetings.
• Track site network awards and milestones (first authorship, first patient enrolled in study, worthy site selection) and alert BD team to ensure posts to social media accounts, email signature blocks, and press release content is updated.
• Register and coordinate all conference attendance (hotels, air travel, expense reimbursement) and assist in preparation for conference with meeting reservations, transportation, exhibition materials, etc.
• Maintain a consistent knowledge base regarding Segal Trials’ current and past study performance in enrollment and data quality to communicate effectively with clients.
• Maintain a consistent knowledge base regarding Segal Trials’ current and past capabilities, including, but not limited to, indications, phases, and types of investigational product to communicate effectively with clients and prospective clients.

Analysis and Reporting:

• Maintain and consistently update a list of Segal Trials Physician Investigators and their trial history.
• Maintain and regularly update the site network forecast report (enrollment periods per site)
• Create and maintain a pipeline report within business development technology software with trials in all stages of business development and provide to executive leadership and management team members regularly as directed.
• Ensure maintenance of Upcoming Awarded Studies report within business development technology software system.

Goal Performance:

• Complete and submit CDAs within 1 business day of receipt, unless otherwise specified by BD Manager.
• Complete and submit Feasibility Questionnaires within 3 business days of receipt, unless otherwise specified by BD Manager.
• Obtain new leads generated from completion and submission of FQs.
• Obtain new leads generated from his/her research efforts (clinicaltrials.gov, etc.)

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES::

• Possesses strong organizational skills.
  • Able to prioritize, delegate, direct, support, assign and evaluate others’ work.
  • Follows through on assignments.
• Able to work independently.
• Functions well in a high-pressure environment.
• Strong Customer Service orientation
• Goal and solutions oriented.
• Possesses excellent communication skills.
  • Exhibits strong verbal and written communication skills through positive interactions with coworkers, managers, clients, and vendors.
• Displays team collaboration skills.
  • Works effectively and collaboratively with team members to accomplish goals.
• Curious and passionate about learning and innovation.
• Skilled at thoughtful risk taking to accomplish tasks.
• Able to balance tasks with competing priorities.
• Able to accept direction and constructive criticism from supervisors and managers.

REQUIREMENTS:

• 2 years previous experience in clinical research required.
• Previous Sales or business development skills required (Does not have to be healthcare related).
• Bachelor’s Degree preferred.
• Proficiency in English required.
• Proficiency with SharePoint, Microsoft Office, including Outlook and Excel.
• Familiarity with a CRM application required.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Project Manager will handle the day-to-day operations and execution of the Dementia Program. The individual in this position is directly accountable to ensure the following targets are met: enrollment goals, compliance standards, clinical trial milestones, study and site budgets, company and profitability. Additional accountabilities include: clinical quality of care, patient satisfaction, client satisfaction, productivity, revenue enhancement and staff leadership.

The studies will be conducted in several assisted living facilities throughout South Florida by multiple Segal Trials teams. Each team will have a PI, Sub investigator, Raters, Coordinator, Research Assistant, Pharm Tech and Data Entry representative. The Medical Director will provide clinical oversight and the SR. Manager of Rating & Pre-Screening Operations will provide rater oversight and collaborate with this individual on project management. The Project Manager will receive support from the President, Medical Director, Human Resources, QA, Rater Operations, and Administrative Operations.

Primary Responsibilities:

• Manage interviewing and hiring process for necessary staff.
• Ensure data completion and compliance in a timely manner.
• Serve as a liaison with facility personnel.
• Serve as a liaison with Sponsor.
• Plan and track recruitment activities
• Ensure deliverables and timelines are met.
• Coordinate and manage staffing needs in accordance with protocol requirements.
• Ensure each team has adequate equipment and supplies.
• Provide reports to Senior Management and Sponsor as needed.
• Collaborate with Segal Trials President, Medical Director, Human Resources, Finance, and SR. Manager of Rater Operations to ensure enterprise success.
• Ensure trials are being conducted in compliance with applicable requirements.
• Translate strategy into actionable goals for performance and success.
• Oversees employee productivity, building a highly inclusive culture ensuring team members thrive through mentorship.
• Continually investigate and introduce process improvement measures and present suggestions to senior leadership for consideration.

Qualifications:

The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics:

• Minimum B.A./B.S. degree or relevant experience.
• Demonstrated strong coaching and mentoring skills
• Understands R&D Deliverables
• Experience working as a Project Manager for a biotech, pharma, or CRO
• Very detailed oriented.
• Budget & financial management
• Clear and effective communication & diplomacy skills
• Excellent leadership and interpersonal skills; ability to collaborate across disciplines with demonstrated ability to effectively lead multi-disciplinary global teams
• Attention to detail
• Ability to multitask
• Travel required to sites with the Miami-Dade and Broward County areas
• Bilingual

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

Core responsibilities include customer service, direct volunteer liaison duties, tracking of referrals, and organization of patient-related study startup activities.  In addition, responsibilities include working closely with Call Center Lead & Senior Manager of Rating / Prescreening Operations to ensure completion of daily tasks in the department.

Summary of Essential Job Functions:

• Answer incoming calls from potential volunteers, explain studies, conduct phone interviews per IRB procedures and set appointments for new patients in all outpatient offices or via phone. Enter information into CTMS.
• Calls volunteers referred by Central/National Campaigns & pharmaceutical companies.
• Tracks and maintains call center waitlists and qualified waitlists for upcoming studies.
• Organizes waitlist data into weekly report.
• Follows up with staff, as appropriate, regarding waitlist needs and progress.
• Collects data regarding marketing campaigns, call center trends, and waitlist correlations.
• Familiarizes self with study protocols.
• Be current on all advertising at each site.
• Adheres to GCP and HIPAA guidelines.
• Directs e-mails to appropriate site staff to address patient concerns or questions.
• Answers main telephone extension and fields phone calls and/or schedules appointments with potential clients.
• Miscellaneous responsibilities incidental to the work described therein.
• Accurate documentation of transportation requests on site calendars
• Maintain Volunteer Satisfaction and Professionalism throughout all calls.

Skills And Qualifications:

• Ability to deliver information to caller/patient inquiries.
• Strong organizational and time management skills.
• Professional verbal and written communication skills
• Ability to project a professional image through telephone interaction.
• Strong interpersonal and communication skills
• Ability to type 30 wpm.
• Excellent computer knowledge.
• Flexibility, proactive and perseverance.
• Able to work well under pressure.
• Able to handle multiple projects simultaneously.
• Sales Experience (Preferred)
• Bilingual English/Spanish (Required)

Education:

• High School diploma or equivalent or higher education

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations.

Primary Responsibilities:

• Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines.
• Identify potential problems or inconsistencies and take action as appropriate.
• Articulate protocol issues to CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator, and other members of the study team.
• Collect initial subject health and demographic information by interviewing subjects and accessing other appropriate sources.
• Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator.
• Ensure a flow of communication including telephone conferences between subject, study staff, referral sources and recruitment team, Sponsor and/or CRO, Monitor(s) and Auditors, if applicable.
• Perform clinical tasks including, but not limited to: vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging.
• Maintain timely internal source documentation as well as sponsor-required information.
• Maintain timely EDC data entry and query resolution.
• Maintain timely CTMS data entry of patient visits and study information.
• Complete Verification of subjects before consenting.
• Report hospital census data, if applicable.
• Dispense and maintain accurate records of investigational and study product.
• Educate subject and family members regarding specific studies and clinical drug trials in general.
• Complete all monitor and sponsor queries in a timely manner.
• Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed.

Recruitment Responsibilities:

• Send “All Users” email upon enrollment activation or enrollment closure
• Participate in recruitment planning meetings prior to study start
• Provide weekly updates to Active Studies Report
• Communicate all advertising needs to recruitment team
• Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials
• Communicate the need for study or company flyers

Secondary Responsibilities:

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Assisting in establishing and enforcing departmental standards

Contributes to team effort by

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to the organization and departmental processes
• Helping others at the site to achieve site goals
• Performing other duties as assigned
• Support the organization’s mission and goals

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training
• Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings

Skills And Qualifications:

• CCRC or CCRP certification preferred
• Strong motivational skills and abilities – promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain a professional and positive attitude
• Detail Oriented
• Strong critical thinking skills
• Strong ability to multi-task
• Strong computer skills
• Ability to support and demonstrate the mission and goals of the company
• Excellent interpersonal and customer service skills
• Knowledge of medical terminology and clinical practices

Experience:

At least 2 years of experience as a CRC in clinical research or relevant clinical role

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Principal or Sub Investigator is responsible for the oversight and execution of Psychiatric clinical trials testing new medications on the behalf of the sponsor/pharmaceutical companies. The investigator promotes Good Clinical Practices (GCP) in the conduct of Clinical Investigations by ensuring the integrity of data generated at the site and directing the conduct of the clinical investigation as to the guidelines issued by State and Federal Authorities and the Sponsor. The Investigator works collaboratively with the study team and regulatory personnel to ensure welfare of study participants.

Summary of Essential Job Functions:

• Responsible for maintaining up-to-date curriculum vitae.
• Provide Sponsor and IRB with documentation of credentials as required.
• Maintain all required licenses to practice and execute the job as PI or Sub-I.
• Assume responsibility as the Principal or Sub-Investigator for the duration of clinical trials.
• Demonstrate the proper education, training and experience to conduct the clinical investigation.
• Disclose conflicts of interest as described in the regulations.
• Perform psychiatric evaluations.
• Evaluate and screen potential subjects based on study eligibility criteria.
• Perform and review psychiatric ratings performed by raters in accordance with the clinical study protocol.
• Complete protocol specific training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols.
• Complete all documentation, paper and electronic, as required per protocol.
• Provide oversight and ensures proper delegation of duties to appropriate staff.
• Provide and maintain updated study related documentation as required by the clinical research trial to ensure data integrity.
• Evaluate and report safety reports, protocol noncompliance and any other protocol specific reports.
• Follow requirements for FDA form 1572.
• Collaborate with operational and management team to ensure site goals are met.
• Attend Investigator Meetings and educational seminars.
• Travel to Investigators meetings as needed.
• Provide on call outpatient and/or inpatient coverage to subjects enrolled in clinical studies.

Skills And Qualifications:

• Ability to read, write, and interpret the English language (Bilingual/spanish preferred)
• Possess a valid M.D. or D.O. degree
• Board Certification in psychiatry or in process of obtaining one.
• Active DEA license, or able to obtain one
• Active license to practice medicine in the state of Florida, or ability to obtain one immediately
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required

Education:

• Possess a valid MD or DO medical degree
• Board certification in psychiatry

Experience:

1-3 years experience conducting psychiatric clinical research trials as either a PI or Sub-investigator, or other relevant experience

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Clinical Research Assistant is responsible for assisting the research coordinator and other staff with completing protocol procedures and processing laboratory samples for shipment. Promote good clinical practices (GCP) in the conduct of clinical investigations. All duties carried out by the research assistant are done so in accordance with company policies, SOPs, GCP, and applicable local, state and federal regulations.

Primary Responsibilities:

• Perform medical diagnostic tests such as electrocardiograms, blood pressure checks, etc.
• Collect and process blood and urine samples per protocol requirements.
• Professionally interact with subjects, visitors, staff, and other healthcare professionals.
• Maintain laboratory inventory.
• Sanitize and stock treatment rooms and exam rooms.
• Dispose of and replace biohazard waste in lab and exam rooms per OSHA requirements.
• Perform administrative tasks as needed.
• Troubleshoot any study issues.
• Articulate all pertinent issues to the Site Lead, Site Manager, and/or PI.
• Maintain timely source documentation.
• Complete all monitor, sponsor and lab queries in a timely manner.
• Accurate and timely entry into CTMS.
• Other duties and responsibilities as assigned or directed.

Secondary Responsibilities:

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Assisting in establishing and enforcing departmental standards

Contributes to team effort by

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to the organization and departmental processes
• Helping others at the site to achieve site goals
• Performing other duties as assigned
• Support the organization’s mission and goals

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training
• Attending and participating in recruitment meetings

Additional skill set:

• Strong motivational skills and abilities – promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain a professional and positive attitude
• Ability to communicate in a clear and professional manner
• Adhere to GCP
• Attention to detail and accuracy in completing tasks
• Strong ability to multi-task

Education:

• High School Diploma
• CMA or RMA required

Experience:

At minimum 2 years’ experience in phlebotomy

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Licensed Practical Nurse will be expected to understand the full complement of duties typically assigned to an LPN at Segal Institute for Clinical Research and to execute these tasks as needed.

Summary of Essential Job Functions:

• Provide bedside care
• Administer medications and document therapeutic effects
• Take vital signs (temperature, blood pressure, pulse and respiration)
• Assist with resident comfort
• Perform other tasks as assigned

Skills And Qualifications:

• Active Florida LPN license
• Current CPR
• Experience with psychiatric patients and chemically dependent patients preferred.
• Must have a clear background screening
• The ability to read and communicate in English both verbally and in writing
• Working knowledge of Nurse Practice Acts
• Valid Driver’s License

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Quality Control Analyst collaborates with management and staff to develop, verify and implement procedures, in accordance with Good Clinical Practice (GCP) and federal regulations, that support Segal Trials in accomplishing its quality management goals. Under the supervision of the Director of Clinical Operations, the individual in this role reviews patient and study data to verify research protocol compliance and adherence to protocol, as well as data integrity, and data control principles. The scope of the Quality Control Analyst extends to all study-related data collection, including Clinical Trial Management Systems (CTMS), Regulatory documentation, Source documentation, Electronic Data Capture, and other systems, as appropriate.

Summary of Essential Job Functions:

• Perform study subject reviews, ensuring protocol compliance as well as compliance with site SOPs and all other applicable regulations. Such reviews will include, but not be limited to, the following:
  • Informed Consent Forms (ICFs)
  • Subject study eligibility
  • Adverse events (AEs)
  • Concomitant medication
  • Investigational Product (IP) accountability
  • Investigational Product storage
  • Progress Notes
  • Medical history
  • Medical records
  • Hospital records (when applicable)
  • Lab values and documentation
  • Other diagnostic tests
  • Ratings scales
  • Other Visit procedures and examinations
  • Progress Notes
  • Investigator Notes
  • Regulatory documents
  • Other collected and documented data, as appropriate
• Confirm site compliance measures and documentation including, but not limited to, the following:
  • Equipment calibration
  • Temperature logs
• Perform data comparisons between Electronic Data Capturing (EDC) systems and Source Documents to ensure all data is initially gathered in Source Documents, and data is correctly transcribed into EDC.
• Perform data comparisons between data collected during a specific clinical trial and the related protocol to ensure that generated during the study adheres to protocol requirements
• Verify the integrity of all clinical trial data in accordance with ALCOA-C principles (accurate, legible, contemporaneous, original, accurate and complete).
• Utilize a dedicated QC checklist for study, subject and site compliance reviews.
• Maintain thorough documentation to confirm resolution of any issues of concern.
• Provide regular reports to the Director of Clinical Operations and Management Teams to advise leadership of quality issues and to guide enterprise process corrections & improvements.
• Work cooperatively with clinical site staff, investigators, regulatory staff, and other Segal Trials’ employee groups to effectively communicate quality concerns, to train or retrain staff as needed, and to guide improved quality and compliance measures throughout the enterprise.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

Skills And Qualifications:

• Possesses exceptional attention to detail.
• Able to work independently with little feedback or direction.
• Functions well under high-pressure conditions.
• Possesses highly effective communication skills
  • Exhibits highly effective verbal and written communication skills through positive interactions with coworkers, managers, clients and vendors
• Models team collaboration skills.
  • Works effectively and collaboratively with team members to accomplish goals.
• Independently displays a passion to learn and innovate and maintains knowledge of industry development through personal readings and individual trainings.
• Balances tasks with competing priorities effectively without direction from supervisor.
• Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.

Requirements:

• 2+ years of relevant work experience in clinical research.
• Bachelor’s degree in Science or Business required
• Proficiency in English required.
• Proficiency in English and Spanish preferred
• Proficiency with Microsoft Office, including Outlook and Excel

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Marketing Specialist is responsible for the planning, development, and execution of the Segal Trials marketing efforts across all the ST network. They ensure marketing functions support the company in meeting its contract and enterprise goals. The Marketing Specialist approaches their role from a result driven and goal-oriented perspective, approaching their tasks with energy and an innovative mindset to ensure that Segal Trials’ goals are met. The person in this role works with marketing, the call center, outreach coordinators and clinical operations to design and implement patient recruitment programs, achieving patient participation growth for assigned indications, studies, and for the enterprise as a whole.

DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Facilitate the marketing and advertising initiatives for all clinical trials within the site network, including creative and ad placement and creation of IRB Ad packages
• Maintain knowledge of all currently enrolling trials and their enrollment statuses, including which trials are high priority status
• Communicate marketing strategies and advertising campaigns to Patient Recruitment Manager during development of recruitment plans and pivot/update as needed throughout the life of the trial
• Understand ROI of each marketing initiative
• Attend regular recruitment meetings to review the enrollment status of all trials, sites, and the enterprise as a whole and adjust strategies as needed to achieve set goals
• Ensure all social media outlets, the company website, and all other public materials are up to date with current and upcoming studies, along with any other marketing communications
• Request edits on company website and monitor the results to ensure accuracy of changes (i.e. staff changes, announcements, news, blog content, and enrolling studies)
• Facilitate text and email blasts as requested
• Assist with preparation, coordination and execution of patient events and company events, parties, meetings, and conferences
• Ensure consistency in the company’s brand messaging across all platforms
• Understand advertising budgets for all clinical trials; ensure proper utilization, maintain knowledge of remaining dollars, and request increased advertising dollars, as needed
• Act as a liaison, communicating with pharmaceutical company study representatives as needed for recruitment-based discussions
• Meet regularly with managers to review goal performance and return on advertising investments
• Maintain an indication-based library of ads, supporting cost efficiencies and ease of use
• Provide support to the Call Center and Outreach to ensure the successful organization of all leads resulting from marketing initiatives
• Assist with community outreach and educational presentation scheduling and materials
• Maintain portals ensuring all initiatives are up to date with currently enrolling studies, proper collateral is used, and leads are distributed appropriately within the CTMS system or call center team
• Oversee Refer a Friend program and provide updates and inefficiencies if noted; ensure proper marketing of program across all enterprise platforms
• Regularly confirm that the volume of leads through various sources (i.e., inbound calls, web contacts, referrals) are adequate to meet study, site, and enterprise goals, and adjust as needed
• Create and distribute all company marketing materials, including branding materials and other collateral that help support company staff at conferences and meetings
• Execute recruitment initiatives such as SEO, Google AdWords, Facebook sponsored/organic ads, and PPC
• Execute all digital marketing campaigns related to recruitment
• Maintain patient testimonials and ensure posts to website, social media, and all-staff emails
• Ensure website blog is regularly updated, expanding blog content and provide opportunities for staff to participate if interested

Analysis and Reporting:

• Maintain portal metric report containing number of leads per portal, indication, status, and success rate
• Maintain advertising calendar for company and sponsor-initiated marketing strategies

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES:

• Possesses strong organizational skills

  • Able to prioritize, delegate, direct, support, assign and evaluate others’ work.
  • Follows through on assignments in a timely manner.

• Demonstrated abilities in performance management

  • Able to influence and encourage others to perform their jobs effectively & responsibly.
  • Successful previous history with training and leading employee teams.
• Able to work independently.
• Functions well in a high-pressure environment.
• Strong Customer Service orientation.
• Goal and solutions oriented.

• Possesses excellent communication skills.

  • Exhibits strong verbal and written communication skills through positive interactions with coworkers, managers, clients and vendors.

• Displays team collaboration skills

  • Works effectively and collaboratively with team members to accomplish goals
• Curious and passionate about learning and innovation.
• Skilled at thoughtful risk taking to accomplish tasks.
• Able to balance tasks with competing priorities.
• Able to accept direction and constructive criticism from supervisors, managers, and peers.

REQUIREMENTS

• Bachelor’s Degree in marketing or a related area.
• 2+ years of previous relevant marketing/ advertising experience.
• Knowledge of marketing tools, and social media management.
• 2+ Years of digital marketing experience.
• Knowledge of graphic design.
• Knowledge of CRM software preferred.
• Proficiency in English required.
• Proficiency in English and Spanish preferred.
• Proficiency with Microsoft Office, including Outlook, Excel, and PowerPoint.
• Historic success with marketing strategy and initiatives.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Clinical Rater is responsible for administering various psychometric efficacy scales, as well as completing interviews/ratings on study participants specific to several study protocols. This person will perform interview/ratings on study subjects to determine current levels of functioning and to create a clinical impression of the study subject’s current presentation throughout the duration of the trials. Clinical interviewing skills are a must, as well as knowledge of DSM IV and 5 diagnoses.

Summary of Essential Job Functions:

• Administer clinical efficacy scales on subjects with various diagnoses such as ADHD, Alzheimer’s Disease, Bipolar Disorder, Major Depressive Disorder, Substance Use Disorders and Schizophrenia.
• Perform diagnostic evaluations.
• Gather information from prospective subjects through a prescreening interview and determine eligibility for research trials.
• Submit accurate data utilizing Good Clinical Practices (GCP) and identified scoring conventions.
• Work with SICR Principal Investigators and coordinators in initiating assessments, and assist them with data query completion and data clarification.
• Assist in maintaining site specified levels of recruitment.
• Interact with Sponsors, Study Monitors and Medical Monitors from pharmaceutical companies in a professional manner.
• Follow Sponsor, or protocol, specific requirements and applicable SICR internal SOPs.
• Utilize technology required to conduct remote assessments.
• Review all medical records.
• Manage subject crises with professionalism and clinical expertise.
• Attend all required investigator meetings and internal SICR meetings; expected travel is 10-15%.
• Successfully complete all sponsor-assigned training through web-portals and meetings to obtain rater certification on specified scales.
• Participate in monthly rater meetings, ongoing rater calibration and training.
• Perform other related duties incidental to the work described therein.

Skills And Qualifications:

• Superior patient interview and diagnostic skills
• Clinical assessment experience preferred
• Bilingual English/Spanish is preferred

Education:

• Master’s Degree or higher in a Psychology related area

Experience:

At least 1 year of experience in a call center or related field.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Principal investigator is responsible for the oversight and execution of Psychiatric clinical trials testing new medications on the behalf of the sponsor/pharmaceutical companies. The investigator promotes Good Clinical Practices (GCP) in the conduct of Clinical Investigations by ensuring the integrity of data generated at the site and directing the conduct of the clinical investigation as to the guidelines issued by State and Federal Authorities and the Sponsor. The Investigator works collaboratively with the study team and regulatory personnel to ensure welfare of study participants. The Principal Investigator oversees execution of the study protocol, delegates study related duties to site staff, as appropriate, and ensures site compliance with study protocols, study specific laboratory procedures, and standards of Good Clinical Practice.

Summary of Essential Job Functions:

• Responsible for maintaining up-to-date curriculum vitae.
• Provide Sponsor and IRB with documentation of credentials as required.
• Maintain all required licenses to practice and execute the job as PI.
• Demonstrate the proper education, training, and experience to conduct the clinical investigation.
• Disclose conflicts of interest as described in the regulations.
• Review Investigators Brochure prior to performing study related activities.
• Evaluate and screen potential subjects based on study eligibility criteria and perform psychiatric evaluations.
• Perform assessments and physical examinations as a part of clinical study procedures.
• Provide ongoing assessments of study subjects including any potential adverse events, or serious adverse events and ensures proper reporting of such events.
• Provide medical management of Adverse Events and emergent events as appropriate.
• Evaluate and assesses laboratory reports and ECG’s
• Follow protocol requirements including concomitant medication allowances and review inclusion/exclusion criteria.
• Perform clinical rounds on patients as required and documents patient care orders.
• Perform and review psychiatric ratings performed by raters in accordance with the clinical study protocol.
• Complete protocol specific training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols.
• Conduct and document training for all delegated individuals tasked with performing any study specific activities in the study.
• Complete all documentation, paper and electronic, as required per protocol.
• Provide oversight and ensures proper delegation of duties to appropriate staff
• Provide and maintain updated study related documentation as required by the clinical research trial to ensure data integrity.
• Evaluate and report safety reports, protocol noncompliance and any other protocol specific reports.
• Follow requirements for FDA form 1572.

Skills And Qualifications:

• Ability to read, write, and interpret the English language
• Possess a valid M.D. or D.O. degree
• Active DEA license, or able to obtain one
• Active license to practice medicine in the state of Florida, or ability to obtain one immediately
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required

Education:

• Possess a valid MD or DO medical degree
• 1-3 years experience conducting psychiatric clinical research trials as either a PI or Sub-investigator, or other relevant experience preferred

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Executive Personal Assistant is responsible for undertaking a variety of administrative, clerical and personal tasks to ensure that the Chief Scientific Officers (CSO) day to day operations run smoothly. The individual is responsible for maintaining organization of his current and future obligations, as well as creating strategies to increase time efficiency in the completion of tasks. The Executive Personal Assistant should be trustworthy and skilled in managing personal and family obligations on a daily basis. The Executive Personal Assistant will ensure that CSO’s time is maximized by effectively managing his personal and professional schedule.

Summary of Essential Job Functions:

• Act as a first point of contact regarding emails, phone calls and/or other communications received.
• Record and distribute minutes of meetings.
• Organize and create Investigator and provider call schedule using excel or similar application.
• Maintain positive relationships with contact points on the behalf of the CSO.
• Act as a liaison between the CSO and following individuals: Managers, Physicians, Consultants, Directors, Pharmacy staff, Hospitals and Clients.
• Update maintain and coordinate CSO’s calendar on a consistent basis and schedule meetings.
• Prioritize and remind CSO of important tasks and deadlines, ensuring that they are completed before or on the anticipated date.
• Assist with the administrative responsibilities related to advisory boards, investigators meetings, and conferences such as CNS summit and ASCP.
• Assist in completion of relevant training, presentation and applications.
• Keep track and renew CSO’s medical licenses, DEA’s, credentialling and board certifications.
• Oversee efficient scheduling of CSO’s personal and professional responsibilities.
• Assist with coordination and preparation of meetings, conferences, interviews and/or other events, including scheduling travel, transport and other necessary accommodations.
• Create and manage filing systems.
• Manage special projects when requested.
• Other administrative activities when required.
• Compile and submit expense reports as required.
• Perform personal errands for CSO as required.

Skills:

• Outstanding communication, listening and customer service skills.
• Ability to maintain utmost confidentiality.
• Excellent interpersonal and organizational skills.
• Hands-on attitude.
• Strong Multi-Task ability.
• Ability to prioritize multiple assignments.
• Detail-oriented.

Requirements:

• At least 2 years of proven experience as Executive Assistant or related administrative area.
• Certification in Office Administration or Management is advantageous.
• Some College or higher-level education.
• Bilingual: English/Spanish Preferred.
• Must have Excellent/Advanced computer skills (Word, Excel, Outlook, Power Point).

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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Summary:

The Business Development Coordinator is responsible for the administrative responsibilities associated within the business development department, including new study leads and the management of data and metrics. Coordinator handles completion of CDAs across all sites, ensuring timely study start up and support of the company’s site specific and company-wide goals. The Coordinator approaches their role from a results-driven and goal-oriented perspective, approaching their tasks with energy and a collaborative mindset. The individual in this position works closely with other Segal Trials departments to ensure enterprise success in compliance with study and non-study regulations but not limited to the study protocol, HIPAA, OSHA, GCP, GDP, CRF, ICH Guidelines and site Standard Operating Procedures (SOPs) and Work Instructions (WIs). Business Development Coordinator ensures that all prospective sponsors and clients are handled with the highest level of customer service and professionalism.

DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Familiarize self with Segal Trials research sites, historical performance, capabilities, mission, and vision to represent the company with the utmost professionalism.
• Handle the timely execution and submission of CDAs (within 1 business day of receipt) and assess if all of company’s investigators have been provided with the potential trial opportunity.
• Handle the timely execution and submission of Feasibility Questionnaires (within 3 business days of receipt).
• Handle the accurate and timely completion of all business development technology systems (CTMS, Devana, etc.) related to study progress milestones, study contact information, and uploading of appropriate documents.
• Maintain and regularly update PI Performance metrics (# studies by indication, investigator experience) within business development collateral.
• Maintain and regularly update the site network forecast report (enrollment periods per site)
• Attend SSV/PSSVs for all site network departments and gather accurate enrollment timelines, enrollment expectations and site selection information.
• Update the CVs of Principal Investigators, Sub-Investigators, Raters, Coordinators, Research Assistants, and Contractors with new studies awarded and completed, authorships, seminars, posters, abstracts, awards, and licensures.
• Update internal site reports with current studies, upcoming awarded studies, and new studies in each site’s pipeline and ensure all study metrics are maintained with accuracy using the business development technology systems.
• Create and maintain collateral to be used in business development functions, with special attention to FDA Approved Medications, Site Profiles, Staff Biographies.
• Attend and facilitate meetings with relevant sponsoring pharmaceutical companies and Contract Research Organizations, such as preferred partnership meetings.
• Track site network awards and milestones (first authorship, first patient enrolled in study, worthy site selection) and alert BD team to ensure posts to social media accounts, email signature blocks, and press release content is updated.
• Register and coordinate all conference attendance (hotels, air travel, expense reimbursement) and assist in preparation for conference with meeting reservations, transportation, exhibition materials, etc.
• Maintain a consistent knowledge base regarding Segal Trials’ current and past study performance in enrollment and data quality to communicate effectively with clients.
• Maintain a consistent knowledge base regarding Segal Trials’ current and past capabilities, including, but not limited to, indications, phases, and types of investigational product to communicate effectively with clients and prospective clients.

Analysis and Reporting:

• Maintain and consistently update a list of Segal Trials Physician Investigators and their trial history.
• Maintain and regularly update the site network forecast report (enrollment periods per site)
• Create and maintain a pipeline report within business development technology software with trials in all stages of business development and provide to executive leadership and management team members regularly as directed.
• Ensure maintenance of Upcoming Awarded Studies report within business development technology software system.

Goal Performance:

• Complete and submit CDAs within 1 business day of receipt, unless otherwise specified by BD Manager.
• Complete and submit Feasibility Questionnaires within 3 business days of receipt, unless otherwise specified by BD Manager.
• Obtain new leads generated from completion and submission of FQs.
• Obtain new leads generated from his/her research efforts (clinicaltrials.gov, etc.)

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES::

• Possesses strong organizational skills.
  • Able to prioritize, delegate, direct, support, assign and evaluate others’ work.
  • Follows through on assignments.
• Able to work independently.
• Functions well in a high-pressure environment.
• Strong Customer Service orientation
• Goal and solutions oriented.
• Possesses excellent communication skills.
  • Exhibits strong verbal and written communication skills through positive interactions with coworkers, managers, clients, and vendors.
• Displays team collaboration skills.
  • Works effectively and collaboratively with team members to accomplish goals.
• Curious and passionate about learning and innovation.
• Skilled at thoughtful risk taking to accomplish tasks.
• Able to balance tasks with competing priorities.
• Able to accept direction and constructive criticism from supervisors and managers.

REQUIREMENTS:

• 2 years previous experience in clinical research required.
• Previous Sales or business development skills required (Does not have to be healthcare related).
• Bachelor’s Degree preferred.
• Proficiency in English required.
• Proficiency with SharePoint, Microsoft Office, including Outlook and Excel.
• Familiarity with a CRM application required.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

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DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Liaising with internal departments to determine recruitment needs.
• Determining selection criteria, hiring profiles, and job requirements for vacant positions.
• Sourcing potential candidates through online company career portals, recruitment sites, job boards, social platforms, as well as print media, posters, and flyers, when required.
• Managing hiring processes via electronic Applicant Tracking Systems.
• Evaluating applications and screening candidates via calls or emails, as well as facilitating pre-interview assessments.
• Compiling interview questions and conducting in-person or video call interviews with shortlisted candidates.
• Preparing hiring forecasts as part of the company’s strategic planning.
• Documenting processes and fostering good relationships with potential candidates and past applicants.
• Developing hiring strategies and procedures in line with industry trends, as well as keeping informed of advancements in the field.
• Assist with new hire orientation and on boarding.
• Act as a point of contact for new hires as they navigate the organization.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES:

• Possesses exceptional attention to detail.
• Able to successfully complete complex tasks accurately and quickly, despite frequent interruptions.
• Displays excellent organizational and planning skills, including the ability to maintain effective systems.
• Balances tasks with competing priorities effectively with little direction from supervisor.
• Functions well under high-pressure conditions, including managing tight and changing timelines.
• Possesses highly effective communication skills.
• Exhibits highly effective verbal and written communication skills through positive interactions with coworkers, managers, clients, vendors, industry experts, and others.
• Models team collaboration skills by working effectively & collaboratively to accomplish goals.
• Independently displays a passion to learn and innovate and maintains knowledge of industry development through personal readings and individual trainings.
• Able to manage sensitive information with confidentiality.
• Solicits & responds positively to direction & constructive criticism from managers and peers.

REQUIREMENTS:

• 4 years of relevant work experience in Human Resources or related field preferred.
• Bachelor’s degree in human resources management, or similar preferred
• 2-3 years of experience as a talent acquisition specialist, or similar.
• Proficiency in applicant recruitment portals
• Ability to liaise with internal departments and develop hiring strategies and profiles.
• Advanced knowledge of effective hiring platforms that attract suitable applicants.
• Exceptional ability to screen candidates, compile shortlists and interview candidates.
• Experience in creating awareness of the company brand and establishing professional relationships with candidates.
• Proficiency in documenting processes and keeping up with industry trends.
• Excellent interpersonal and communication skills.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY