Physician Investigator (PI) MD / DO - Clinical Trial Oversight SRI Clinical Trial Unit, Plymouth, MIJob Locations

　　US-MI-Plymouth

　　ID 2024-5764  

　　Category Biosciences  

　　Position Type Temporary Part-Time  

　　Worker Type HybridOverview

　　SRI Biosciences is building upon its expertise in research and discovery and preclinical drug development. It offers clinical trial services and strategic development support for biotechnology and device companies, university investigators, and other federal and commercial clients and partners on both a national and global scale. SRI's Clinical Trials Unit fill a need, particularly for small or virtual biotechnology companies, which are not prioritized by large Contract Research Organizations. The unit, open since 2014, leverages existing core competencies and relationships to provide an agile, top-tier development organization with the capacity to carry programs from concept to clinic. In addition to the execution of clinical trials, SRI also provides early strategic guidance in the refinement of efficient, scientifically sound product development plans leading to a future drug or device that addresses a well-defined unmet medical need and that will be well positioned for significant market share at launch. Our 13-bed, 3-infusion recliner, state-of-the-art clinical trial facility is 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.This position will at times require the P.I. to be onsite in our Plymouth, MI facility as needed, if needed, but the majority of the work can be done remotely.

　　Responsibilities

　　The Physician Investigator (PI) at SRI's Clinical Trial Unit (CTU) will serve as a Principal or Sub-Investigator for federal and commercial clinical trials involving pharmaceutical and medical devices . In this position, the PI will report to the Director of the CTU and interact with Mid-level Practitioners, Clinical Research Nurses, and other Research Personnel. The PI will also work with other 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. The PI will be the lead person to make medical decisions for designated clinical trials. They will be fully supported by operational staff on the Unit.  In addition, the PI may provide critical feedback on protocol designs, including informed consent forms, data and safety monitoring plans, clinical data summaries, and other study-specific documents. They may also participate in dose escalation committee meetings and provide input on operating procedures and quality assurance initiatives.This role offers a unique opportunity for a licensed physician looking to build on previous clinical research experience and develop a strong background as an established Physician Investigator (PI) in federal and commercial spaces in their therapeutic area. The CTU facility is different from a hospital setting and is more similar to an outpatient clinic. The growing team at the CTU is comprised of a Director of Clinical Trials Operations, Clinical Site Manager, Clinical Trial Associate, and Licensed Clinical Nurses with strong experience in clinical trials. Compared to larger academic settings, the CTU team is a smaller team that thrives in a fast-paced learning environment and incorporates a strong team-based approach that prioritizes quality and efficiency. This role is ideal for PIs looking for a research team with a history of credibility, reliability, and success in carrying out clinical trials and operational processes required from start-up to close. This permits PIs at the CTU a unique level of f