- Contractor shall manage and conduct the clinical trial in line with the protocol as a study lead Principal Investigator or AssociateInvestigator and will be responsible for assuring the health and welfare of study participants.
- Contractor shall provide the appropriate medical direction, strategy, coverage, and be perform/oversee medical procedures associated with the protocols and associated trial-related medical decisions.
- Contractor shall identify any AEs and/or SAEs, their relationship and severity, and assist in the resolution as appropriate of any AEs and/or SAEs and sequelae, to include acute reactions to product administration.
- Contractor shall interact with multi-disciplinary work group answering queries from investigators, coordinators and research monitors, ensuring that medical issues are appropriately considered with respect to highly complex data findings and escalated as needed.
- The Contractor shall have a significant impact on the creation, composition, maintenance, and execution of clinical trial protocols, including study related budgets, reports, timelines, presentations, and manuscripts.
- Contractor shall maintain licensure, credentialing, medical board certification, and BLS/ACLS certification as well as attend training, understand and implement the concepts of said training for ethical research practices such as CITI, HIPAA, and Good Clinical Practice training.
Required Knowledge, Skills, and Abilities: Thorough knowledge of clinical medicine and the procedures and techniques necessary for performing research tasks; knowledge of medical science and the development of clinical research programs; experience in the design of clinical research trials preferred; ability to communicate effectively; ability to make effective presentations and publish; excellent verbal, written and interpersonal skills.
Minimum Education/Training Requirements: M.D., D.O., or equivalent degree
Minimum Experience: (MD or DO) Licensure to practice medicine within the continental United States; board certified or board eligible for certification in the specialty associated with the clinical research program.