The Segal Institute for Clinical Research recruitment team is looking for quality people, because our continued success has lead to our growth. Please fill out the form below and copy and paste your resume. Someone will be in touch with you shortly.

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OPEN POSITIONS




Reports to: Rater Supervisor and Clinical Operations
Department: Medical and Clinical

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.

APPLY

Reports to: Site Lead & Site Manager
Department: Clinical

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.

APPLY


Reports to: Site Lead & Site Manager
Department: Clinical

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 preferred

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.

APPLY

Reports to: Director of Clinical Operations
Department: Clinical Operations

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.

APPLY

Reports to: Site Administrator/Inpatient Site Manager

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.

APPLY





Reports to: Chief Scientific Officer/ Medical Director
Department: Medical & Clinical

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.

APPLY