Clinical Research Coordinator

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration.

The Clinical Research Coordinator II fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator II is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. 

 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

1. Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure.
2. Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required.
3. Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support.
4. Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
5. Collaborates with study investigators in determining eligibility of potential participants in clinical trials.
6. Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
7. Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
8. Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. 
9. Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability.
10. In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
11. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
12. Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. 
13. Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to guidelines.
14. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives.
15. Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations.
16. Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research.
17. Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management.
18. Provides process improvement solutions and collaborates on the implementation of the solutions.
19. Additional responsibilities may include working directly with other vendors and/or sponsors. 
20. Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law