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

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.

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 flexibility that enables them to focus on their respective responsibilities and less on the operational logistics required of clinical trials (hiring, budgeting, staffing, recruitment, etc.). Also unique to SRI are the collaborative opportunities to work with various SRI Divisions with renowned scientific experts (Biosciences, Education, Advanced Technology and Development, and others). Opportunities for collaboration both within Biosciences and cross-divisionally may become available within this role. The CTU works with SRI’s Business and Development team and external organizations that allow for various therapeutic trial opportunities to be funneled to the CTU. PIs with a private practice or access to patients interested in clinical research are encouraged to apply. Internal Medicine and Infectious disease specialists are also highly encouraged to apply, although any specialty is welcome.

• 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, including efficient recruitment of subjects
• Provide, in collaboration with operational/clinical team members, feasibility assessments of all new, applicable sponsor inquiries
• Review and evaluate protocols and provide clinical and scientific support for relevant studies
• Attend study initiation meetings, as applicable
• Help to address IRB questions as required
• May assist Clinical Operations and sales/marketing efforts
• Assist during site audits (SRI, FDA, or client-initiated) for relevant studies
• Perform pre-study physical examinations, review lab data, ECGs and other medical information to ensure volunteers are appropriate 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 in accordance with applicable regulations and policies
• Review and sign CRFs/eCRFs to attest to the accuracy of content
• In collaboration with one or more fellow investigators, provide "off-hour" coverage in case of issues or emergencies that merit medical attention.

Required:

• M.D. or D.O. with active license to practice medicine in the state of Michigan
• Active U.S. Board Certification
• 3-5 years of experience as a practicing physician
• Experience in conducting clinical trials as a PI or Sub-I
• No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by FDA
• Exceptional clinical and communication skills
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required
• Able to work with in a team-based environment
   

Preferred:

• Internal Medicine or Infectious Disease specialties ideal but not required
• Active private practice with patients available for clinical research or access to patients who may be interested in clinical research
  • ACRP certification
  • At least 2 years of experience in conducting clinical trials as a PI or Sub-I
• Experience with different Clinical Trial Phases (I-IV)
• Background as a PI working on commercial trials
• Grant-work experience
• Ability to travel to site location (Plymouth, MI) as needed (schedule is flexible)

The pay range is: $102.00 to $130.50. Hourly pay ranges will vary and are based on several factors, including market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/.

SRI International, an over 75-year strong pioneering research institute, has a rich history supporting government and industry. Our innovations have created new industries, billions of dollars in market value and lasting benefits to society. SRI is organized around broad disciplines and capabilities, with research and development divisions and labs to groups who excel at identifying new opportunities, developing products and creating custom solutions. Our organization is driven by impact - delivering unique solutions for the world's important challenges and transforming ideas into reality for clients and partners.