•Performs the duties of a Principal Investigator or Sub-Investigator in various clinical research studies ranging from phase I-IV (phase of research may be dependent upon site).
•Providing medical direction for the ongoing development and implementation of the clinical strategy and providing input regarding communications between the company, contractors, volunteers and sponsors.
•Developing safety monitoring and reporting plans for clinical studies and ensuring quality of medical program deliverables in accordance with quality assurance project plans and standards.
•Reviews and interprets clinical laboratory tests, ECGs, medical history data, and other clinical information regarding potential and enrolled study subjects to evaluate eligibility or ongoing participation.
•Obtain medical histories and performs physical examinations of potential and enrolled study participants.
•Maintains familiarity with, and apply, applicable regulatory documents (e.g. 21 CFR, ICH guidelines, etc.) and regulations.
•Coordinates with other investigators and clinical staff to ensure acceptable medical coverage.
•Maintains familiarity with roles and responsibilities of a Principal Investigator (e.g. Good Clinical Practice).
•Provides advice to operations and supporting departments regarding medical aspects of subject participation and study conduct.
•May be required to manage staff in the Medical Affairs Department or any assigned direct reports including but not limited to pharmacy staff and Physician or Medical Assistants.
•Provides advice and input during the feasibility process.
•May be required to interact with clients to provide a medical perspective during study conduct or study feasibility process.
•Providing leadership and direction to resolve medical emergencies, including being available on-call to answer questions
•Providing supervision during duties
•Assisting in hiring, recruiting and retention of key high caliber staff in support of the development project