Clinical Research Coordinator
Job Description

Mission Statement: We provide a service for trial participation in the Ormond Beach community demonstrating by our actions the love of Christ to everyone with whom we come in contact. We provide studies in outpatient multi-therapeutic areas focusing on obesity, metabolic disorders, HIV and other Infectious Diseases.

Overview:
Manage the conduct of clinical research trials under the direction of the Principal Investigator and/or Sub-Investigators.

Duties include, but are not limited to:
1. Possess a sound and in-depth understanding of each protocol that has been assigned as your primary responsibility
2. Prepare for and attend the study initiation visit
3. Review the protocol summary sheet and the informed consent form for accuracy and clarity
4. Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate
5. Ensure the current approved Informed Consent is signed before subjects are screened and enrolled
6. Review the Informed Consent Form and follow-up procedures with potential study subjects
7. Screen and enroll study subjects
8. Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility
9. Manage study related activities, subject compliance and documentation
10. Ensure adherence to protocol requirements
11. Ensure that the randomization procedure is followed as per protocol guidelines
12. Ensure timely and accurate study drug distribution
13. Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
14. Assist investigators in assessment of subject response to therapy
15. Review and document subject compliance with medications and visits
16. Review laboratory data, inform investigator of abnormal values and document
17. Report to primary care provider as appropriate
18. Schedule subjects for follow-up visits
19. Specimen collection and processing, storage, and shipment – to include phlebotomy
20. Document protocol exemptions and deviations
21. Attend study-related Investigator Meetings as appropriate
22. Maintain source documentation for all data entered, including progress notes, lab data, and procedure reports
23. Record data as directed using the appropriate media or platform and follow procedures for access and security for electronic data entry
24. Review keyed data for accuracy as needed
25. Send data to the data collection center on a timely basis
26. Correct and edit data as directed and as appropriate
27. Gather information, document and report adverse events to the Principal Investigator as outlined in the protocol
28. Gather information, document and report serious adverse events to the Principal Investigator, Sponsor, and IRB (others as required by funding source or as outlined in the protocol).
29. Communicate regularly with the Principal Investigator, Monitor, and others responsible for the conduct of the research trial, about study-related issues
30. Assist the Regulatory Specialist to prepare for, and assist during, Sponsor quality assurance audits and/or FDA regulatory inspections
31. Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).

Skills and Knowledge:
1. Interpersonal and communication skills – interact effectively with professionals, administrative staff, sponsors and regulatory representatives, patients, potential subjects, and referral sources
2. Experience in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting, and source documentation, trial management)
3. A thorough understanding of regulatory requirements, principles of GCP, and biomedical research ethics
4. Training that is appropriate to anticipated duties
5. Familiarity with data entry software
6. Willingness to work as part of a team with staff and volunteers

Salary and Benefits:
1. Hourly pay
2. PTO
3. Health Insurance as per Benefits Plan

Reports to:
1. Peninsula Research, Inc. Lead Coordinator