Under general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists with protocol submissions, database enhancements, and budget preparation.
Duties and Responsibilities:
1. Analyzes highly complex data gathered on clinical research studies.
2. Interprets complex clinical research data.
3. Conducts clinical testing, develops protocols and assures all protocol procedures are approved.
4. Prepares reports for presentation in conferences and seminars.
5. Mentors, trains and reviews the work of less experienced clinical research staff.
6. Develops work flow policies and procedures, prepares manuals and documents related to operations of the function.
7. Oversees the clinical assessments of the study subjects including but not limited to screening, evaluation and testing of the subjects.
8. Oversees data collection, processing, storage, inventory and quality control for clinical research studies.
9. Assists in budget preparation and negotiation.
10. May prepare and ensure grant applications, IRB / GCO documents are submitted.
11. Coordinates protocols and human subject approvals between various sites.
12. Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
13. May obtain informed consent under general supervision of the Investigator(s) and educate participants regarding study requirements
14. Performs other related duties.