Clinical Research Coordinator

Description

Job Title: Clinical Research Coordinator Date Prepared: 02/27/2017

Status: Exempt EEO: Professional Date Revised: 01/12/2023

Statement of Purpose: The Clinical Research Coordinator (CRC) supports, facilitates, and coordinates the daily clinical trial activities under the direction of the Principal Investigator (PI). The CRC coordinates to support and complete the administration of the compliance, financial, personnel and other related aspects of the clinical study. Ensures that the best interests of all participants and the researchers are protected.

Essential Functions:

1. Coordinates with the PI, and the Director of Clinical Research (DCR); collaborating agencies, administration, and departments to help ensure that the clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures.  
2. Collaborates with the PI and DCR to develop materials and tools necessary to appropriately train study participants in the conduct of the study around issues of protocol requirements, schedule of visits, and compliance. Ensures training is completed and documented according to all requirements  
3. Assists PI and DCR in the communication of study requirements and training compliance to all team members involved in conducting the study. 
4. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. 
5. Assesses, records and reports symptoms, reactions, treatments, and changes in clinical trial participant conditions.
6. Performs EKG’s, Venipunctures, Injections, infusions, and other procedures as required by the clinical research project. 
7. Register participants in the appropriate coordinating center and billing matrix as required. 
8. Coordinate participants tests and procedures. 
9. Collects data as required by the protocol. 
10. Maintains adequate inventory of study supplies. 
11. Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate venue. 
12. Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. 
13. Coordinates and facilitates monitoring and auditing visits.
14. Documents and reports all required information and submits all study materials according to policies and procedures set by the sponsoring agencies and company protocol. 
15. Establishes and organizes study files including regulatory binders, study specific source documentation and other materials. 
16. Assists the PI and DCR in study feasibility assessments as requested. 
17. Attends Clinical Research meetings as required or requested by the DCR. 
18. Prepares all study materials as requested by the PI including but not limited to informed consent documents, case report forms, enrollment logs, and drug/device accountability logs. 
19. Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research and adheres to all legal standards of professional practice. 

20. Demonstrates courtesy, compassion, and respect in all interpersonal and intra-professional relationships with CAN clients, staff, visitors, and partners.

21. Promotes and practices CAN Community Health Inc’s mission and values and follows its policies and procedures.

22. Ensures confidentiality is maintained by entire team regarding patient/client information in accordance with HIPAA, professional and departmental standards.

23. Assisting nearby CAN clinics that are participating in trials.

24. Maintain all Investigator site files, including licenses, CV, and training certificates.

25. Submission of necessary documents to the IRB (initial applications, continuing review, deviations, communications etc.).

Secondary Tasks:

1. Triage patient phone calls and walk-ins and prioritizes emergencies for medical referral.
2. Performs medical intake procedures including labs, vital signs and history.
3. Participates in continuous quality improvement of services rendered to CAN clients.
4. Develops and fosters networking relationships with community and support resources.  

Education/Professional:

1. RN or BSN preferred, or minimum of a bachelor’s degree, Life Sciences or in a health-related field. 
2. CPR Certified

Experience:

1. Minimum 3- years’ experience directly related to the duties and responsibilities specified.