JOB SUMMARY: Clinical Research Coordinator is responsible for all aspects of clinical research studies from patient recruitment to study close out in coordination with clinic and surgery center practices.
EDUCATION AND EXPERIENCE:
1. Medical Assistant or equivalent training preferred
2. CPR Certified
3. Knowledge of CFR ICH GCP Guidelines
4. Clinical Research Certifications desirable
5. Cosmetic Dermatology experience a plus
ESSENTIAL SKILLS AND ABILITIES:
1. Experienced in IRB regulatory submission process and related maintenance documents
2. Knowledge of GCP’s (Good Clinical Practices).
3. Knowledge of Federal Guidelines
4. Knowledge of the California Experimental Subject’s Bill of Rights
5. Knowledge of CFR (code of federal regulations).
6. Knowledge of phlebotomy technique.
7. Knowledge of basic medical assisting techniques.
8. Superior ability in exercising a relatively high degree of initiative, judgment and problem resolution.
9. Strong organizational skills and the ability to multi-task and manage multiple clinical trials
10. Possess excellent interpersonal skills and effectively communicate with patients for study recruitment
11. Team player, detail oriented and self-confident with the ability to work with minimal supervision or independently
12. Proficient computer skills, especially Windows, MS Office, the Internet, and medical software
13. Ability to operate basic office equipment such as a phone, fax, copier, printer, etc.
1. Responsible for overseeing and maintaining all aspects of clinical research trials to ensure adherence to FDA guidelines and study protocols
2. Subject recruitment.
3. Subject screening.
4. Collects laboratory specimens.
5. Enrolls subjects into clinical trials.
1. Directly collects data from subject.
2. Maintains source documents.
3. CRF (case report form) completion and review for accuracy
4. Conducts site monitoring visits and audits.
5. Obtains informed consent.
6. IRB (Institutional Review Board) and Sponsor interaction.
7. Work directly with P.I. or Sub-I physicians.
8. Documentation of laboratory procedures.
9. Documentation of histological procedures.
10. Ensures accurate labeling of slide photos.
11. Filing and maintenance of all study related documents.
12. Test article accountability.
13. Conducts and schedules study visits.
14. Documents adverse events and notifies principal investigator and appropriate agencies.
15. Notifies sponsor and IRB of any serious adverse events.
16. Documents lab results and follows up.
17. Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes.
18. Set up exam room for specific procedure as indicated.
19. Provide patient education and literature.
20. Take pre and post-treatment pictures.
21. Clean pack and sterilize instruments.
22. Assists in cleaning rooms.
23. Monitor physician’s schedule to maintain timely flow.
24. Check voice mail and triage calls according to protocol the same day.
25. Travels to investigator meetings.
26. Participates in and contributes to staff meetings.
27. Other duties as assigned.