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

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:

• Clinical research experience preferred (Will train the right candidate)
• Excellent interpersonal skills
• Excellent written and quantitative skills
• Minimum of Physician Assistant or Psychiatric Nurse Practitioner degree

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.

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.

Reports to: Unit Supervisor
Department: Clinical Operation

Summary:

The Mental Health Technician (MHT) at Segal Trials plays a vital role in overall maintenance of a therapeutic environment and ensures the safety of participants and staff on the research unit.

Summary of Essential Job Functions:

• Ensures that clinical research and related activities are performed in accordance with Federal Regulatory guidelines and sponsor policies.
• Develops a thorough working knowledge of all protocols assigned/delegated so that all study activities are completed accurately and completely.
• Performs safety rounds at determined intervals while documenting findings.
• Oversees general milieu while promoting a safe environment.
• Incorporates non-violent crisis intervention de-escalation techniques to effectively manage the agitated Subject.
• Understands and honors the established research unit rules, regulations, and Policy & Procedures.
• Answers telephone and communicates with other disciplines and facilities, including the coordination of patient transfers from community physicians/healthcare facilities.
• Provides 1:1 observation for patients at risk of self-harm.
• Charts patient observations, following delegated procedures and standards
• Assists nursing with research study procedures including dosing, post dose monitoring and any study assessments as delegated by the research team.
• Assists with any urgent/emergent issues on the unit

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.

Skills And Qualifications:

• Possesses strong organizational Skills
  • Follows through on assignments
• Able to work independently
• Functions well in a high-pressure environment.
• 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.
• Able to balance tasks with competing priorities.
• Able to accept direction and constructive criticism from supervisors and managers.

Education:

• High School Diploma
• 2+ years of relevant work experience working in an inpatient setting.
• Certification in Behavioral Health Technician (CBHT) preferred.
• Proficiency in English required.
• Proficiency in English and Spanish preferred.

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

Reports to: Site Lead, Clinical Operations Team
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.

Summary of Essential Job Functions:

• 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

Minimum Qualifications:

• At least 2 years of experience as a CRC in clinical research or relevant clinical role
• CCRC or CCRP certification preferred

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
• 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

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. 

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

Reports to: Clinical Operations Team, Site Lead, Research Manager (ML Only)

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

Minimum Qualifications:

• High School Diploma
• CMA or RMA preferred
• At minimum 2 years’ experience in phlebotomy

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

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.

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

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

• Master’s Degree or higher in a Psychology related area
• Superior patient interview and diagnostic skills
• Clinical assessment experience preferred
• Bilingual English/Spanish preferred

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

Reports to: Director of Marketing, Outreach Recruitment & Retention
& Pre-Screening Supervisor
Department: Medical, Clinical, Recruitment

Summary:

The Screening Specialist is responsible for completing initial interviews 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 and preliminary eligibility for the current trials. This role may also administer cognitive and various other psychometric assessments, as allowed by Sponsor, as needed. Clinical interviewing skills are a must, as well as knowledge of DSM 5 diagnoses.

Summary of Essential Job Functions:

• Gather information from prospective subjects through a prescreening interview and determine eligibility for research trials.
• Conduct telephone and in-person prescreen interviews of potential research volunteers.
• Obtain detailed medical and psychiatric histories of potential volunteers. 
• Evaluate potential eligibility of interested volunteers and schedule eligible candidates to the appropriate research sites. 
• Maintain knowledge of enrolling and upcoming study protocols at all research sites for proper referrals.
• Build and maintain waitlists of potential volunteers for future trials, including current participation status. 
• Update study recruitment portals as needed.
• Assist in maintaining site specified levels of recruitment
• Follow Sponsor, or protocol, specific requirements and applicable SICR internal SOPs.
• Review subjects medical, psychiatric, and social history with Raters, PI’s, and/or Sub-I’s as needed, to determine eligibility.
• Manage subject crises with professionalism and clinical expertise.
• As needed, train and certify on cognitive assessments to assist sites with subject visits.
• Complete all assigned tracking logs on time and with accurate information 
• Assist with community events and other outreach initiatives 
• Perform other related duties incidental to the work described therein.

Skills And Qualifications:

• Bachelor’s Degree or higher in a Psychology related area
• Superior patient interview and diagnostic skills
• Bilingual (English/Spanish) preferred 

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

Reports to: Director of Compliance and Clinical Operations, Director of Regulatory and Compliance
Department: Quality

Summary:

The QD Training and Development Associate I is responsible for providing oversight of Q-Ricculum,  the research education and training program under the leadership of the Director of Compliance and Clinical Operations and the Director of Regulatory and Compliance. This includes development and management of the Q-Ricculum curriculum, overseeing its implementation and assessing outcomes related to training and education; identifying training and development needs and driving suitable training initiatives, working across ST to ensure employee success, such as development of personnel- and role-specific focused trainings; creating a training program for medical personnel and others in the field to support the organizational mission of ST and the creation and review of clinical research study source documents to be used at the site. This position is a hybrid, working remotely but reporting on site to the various sites, depending on organizational needs and training program requirements on an as needed basis.  

Summary of Essential Job Functions:

Reporting to the Director of Compliance and Clinical Operations and Director of Regulatory and Compliance 

• Development and management of Q-Ricculum, the research education and training program to address employee training needs, including regular assessment of training effectiveness through post-training quizzes and assessments after training and return on investment in the training program on a quarterly basis.    
• Trains staff on policies, Standard Operating Procedures (SOPs), Guidance documents, Work Instructions (WI). 
• Trains and develops staff to ensure operational objectives for ST conform to all relevant federal and state laws, regulations, guidelines; clinical research protocols, internal SOPs and WIs. 
• Develops educational metrics to be reported to Executive Leadership on a quarterly basis.  
• Provides opportunities for ongoing training development in person, written and remotely. 
• Resolves any training-specific problems; Creates study-specific and personnel specific programs to align with the scope of the Research Training Program SOP.  
• Maintains a clear understanding of research education training trends, developments and best practices to assist with ensuring low employee turnover and high retention and study demands to align the training program and strategy. e 
• Development of yearly educational goals aligning with Quality Department and ST goals.  
• Creation and review of source documents 
• Performs other study or educational-related duties as assigned.  

In collaboration with Human Resources (HR) 

• Coordinates all aspects of general employee onboarding, research-specific training and professional development. 
• Ensures new hire orientation and training orientation is adequately documented. 

• Interfaces with all departments to collaborate on training needs to ensure standardization across ST.   
• Identifies and assesses future and current training needs through discussions with supervisors. 
• Develop and implement systems for gauging employee satisfaction and developing leaders in ST.  
• Performs other related duties as assigned.  

Interaction with Quality Department 

• Stays current on all Federal and State regulations.  
• Assists with drafting and updating policies, SOPs, Guidance documents and WI; participates in annual SOP review.  
• Participates in developing Corrective and Preventive Action plans, including training related to findings.  
• Trains and develops staff to ensure operational objectives for the organization are in conformance to all relevant Federal and State laws, regulations, guidelines, clinical research project and trial protocols, internal SOPs and WIs. 
• Performs other related duties as assigned.  

Skills And Qualifications:

• xceptional attention to detail. 
• Strategic thinker and self-starter 
• Familiarity with traditional and modern training methods, tools and techniques 
• Familiarity with talent management and succession planning 
• Ability to conduct a cost-benefit analysis and calculate training ROI. 
• Sound decision-making and organizational skills. 
• Ability to present complex information to a variety of audiences in person, through the written word and virtually.  

• Able to successfully complete complex tasks accurately and quickly, despite frequent interruptions.  
• Displays excellent organizational and planning skills, including the ability to develop effective systems.  
• Balances tasks with competing priorities effectively with little direction. 
• Able to work independently with limited feedback. 
• Functions well in high-pressure situations, including managing tight and changing timelines.  
• Possesses and exhibits highly effective verbal and written communication skills demonstrated through positive interactions with coworkers, managers, clients, vendors, industry experts and others. 
• Models team collaboration skills by working effectively with others to accomplish goals.   
• Independently displays a passion for learning and development.  
• Maintains knowledge of industry developments through self-guided individual training.  
• Able to manage sensitive information with confidentiality.  
• Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.  

Requirements:

• Bachelor’s Degree required, preferably in the biopharmaceutical/healthcare industry or related field. 
• Minimum five (5) years’ experience working in Clinical Research or a related field. 
• Knowledge of industry regulations, including but not limited to HIPAA, OSHA, GCP, GDP, CFR and ICH Guidelines  
• Proficiency in English required. Proficiency in Spanish preferred.  
• Proficiency with Microsoft Office suite and patient database software, Electronic Data Capture (EDC).  

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