Our 13-bed, 3 recliner, state-of-the-art Phase 1 clinicaltrial facility will be located at the Michigan Life Science and InnovationCenter in Plymouth MI, centrally situated near academic medical centers in AnnArbor, Detroit, and Royal Oak and within 20 min of the Detroit InternationalAirport.
Position Summary:
As Physician Investigator you will be responsible for the overall conduct of the clinical trials conducted at the unit. In addition, you will provide critical feedback on protocol designs and the content of supporting documentation, including informed consent forms, data and safety monitoring plans, clinical data summaries, and other study-specific documents. In this unique position, along with the Director of Clinical Operations, you will manage a support staff, interact with the business unit lead, and work very closely with clinical and/or and regulatory personnel from Sponsor organizations (i.e., clients) as well as functional service providers providing key adjunctive support and services during the conduct of clinical trials.
Essential Duties and Responsibilities:
•Responsible for protecting the rights, safety and welfare of study participants
•Responsible for ensuring that the clinical trial is conducted according to the investigational plan, ICH GCP guidelines, and all applicable regulations
•Provide feasibility assessments of all new sponsor inquiries
•Review and evaluate protocols and provide clinical and scientific support
•Liaise with sponsor regarding study design and site capabilities
•Interact with regulatory bodies as relevant to clinical operations
•Attend study initiation meetings
•Address IRB questions and present protocols at IRB meetings, as required
•Oversee maintenance of a database of healthy volunteers (prospective study subjects)
•Take responsibility for the efficient recruitment of subjects in trials conducted by the Phase 1 unit
•Assist Clinical Operations and sales/marketing efforts
•Assist during site audits (SRI, FDA, or client-initiated)
•Perform pre-study physical examinations, review lab data, ECGs and other medical information to ensure volunteers are medically and mentally fit for studies
•Perform on-study and post-study physical examinations, and assess the results of study-specific evaluations (e.g., laboratory studies, ECGs, etc.) in a timely fashion to monitor the physical and mental well-being of study volunteers
•Inform IRB and Sponsor as appropriate of relevant events.
•Review and sign CRFs/eCRFs at the conclusion of the study
•Complete all necessary regulatory documents (e.g., FDA form 1572)
•Weekend and off-hours work as necessary
•Participate in the hiring process for new staff
•Directly and Indirectly manage a diverse team in coordination with the Director of Clinical Operations, including a clinical pharmacologist, office manager, and, indirectly, their direct reports.
Requirements:
•M.D. or D.O ideally with a Specialty in Internal Medicine, Emergency Medicine, or Family Medicine
•Active U.S. Board Certification/DEA license
•Active license to practice medicine in the state of Michigan or an active license that is transferable to Michigan within 4 months
•3-5 years of experience as a practicing physician following internship/residency
•Exceptional clinical and communication skills
•Experience in conducting clinical research, including leadership of, or participation in, at least several clinical trials. Experience with Phase 1 trials is highly desirable but not mandatory RES
•No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation in clinical research by FDA
•Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required
Our 13-bed, 3 recliner, state-of-the-art Phase 1 clinical trial facility will be located at the Michigan Life Science and Innovation Center in Plymouth MI, centrally situated near academic medical centers in Ann Arbor, Detroit, and Royal Oak and within 20 min of the Detroit International Airport.
