Clinical Research Manager
Current• Manage clinical research department including all projects/trials and staff CRAs for large, private GI group practice and ensure delivery and development of clinical operations team against key metrics• Collaborate with all key internal and external stakeholders from start-up activity to study completion including communication with monitors from sponsor companies and CEO for marketing and clinical trial enrollment expenditures and strategies• Source and qualify potential studies for practice including budget negotiation/approval and contract review• Coordinate all activities of Phase II-IV clinical research trials by obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug accountability and compliance• Consistently adhere to and monitor practice adherence to ICH guidelines, Good Clinical Practices, HIPAA, and all applicable regulations/guidelines related to clinical trials• Create and update source documents at study start-up and as needed with protocol amendments through the duration of the study• Recruit study subjects, review subject eligibility and educate study subjects regarding objectives of the study• Conduct clinical research visits including performance of vital signs, ECG, venipuncture, subject e-diary education, or any other procedure necessary for the protocol as ordered by the investigator• Assist in the collection of biopsy samples and/or masked video of protocol-required procedures including colonoscopy, flexible sigmoidoscopy, and esophagogastroduodenoscopy
