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Role Description

SRI's Clinical Trials Unit is seeking an experienced Sub-Investigator (Sub-I) with a background as an Advanced Practice Provider (APP) for a part-time, temporary role in clinical trials research. The Sub-I/APP will support research studies and work within established clinical trial study protocols in collaboration with the Principal Investigator and research team. This role is located in Plymouth, MI, offers a high level of schedule flexibility, with work driven by study activity and planned visits.

Responsibilities

• Perform protocol-required Sub-Investigator duties under the direction of the Principal Investigator (PI), including medical oversight and delegated regulatory responsibilities.
• Conduct comprehensive participant evaluations, including medical history review, physical examinations, and protocol-specific clinical assessments.
• Determine participant eligibility based on inclusion/exclusion criteria and clinical judgment, as delegated by the PI.
• Review, interpret, and assess clinical significance of laboratory results, imaging, ECGs, and other study-required diagnostics.
• Provide ongoing safety oversight, including identification, evaluation, documentation, and management of adverse events and serious adverse events.
• Administer study interventions and treatments in accordance with protocol requirements, clinical standards, and regulatory guidelines.
• Provide study-related clinical consultations and participant education, as required by protocol.
• Participate in clinical decision-making related to protocol deviations, safety concerns, and study-related medical issues, in collaboration with the PI and sponsor.
• Ensure all clinical activities are conducted in strict accordance with study protocols, GCP, and applicable regulatory and institutional requirements.
• Maintain accurate and complete clinical documentation, including source documentation, adverse event reporting, and case report form (CRF) review.
• Review and document study data to support monitoring visits, audits, and regulatory inspections.
• Collaborate with study monitors, sponsors, and internal teams to address clinical queries and ensure data integrity.
• Work closely with the site team to support study execution, including clinical input for screening, enrollment, and follow-up activities.
• Serve as a clinical liaison between research participants, investigators, sponsors, and healthcare providers to support participant safety and study quality.
• Provide clinical oversight, mentorship, and guidance to research staff, as appropriate.
• Contribute clinical expertise to the development and refinement of study protocols, SOPs, and quality improvement initiatives.
• Attend required study meetings, sponsor training, and investigator meetings.
• Maintain clinical licensure and stay current with regulatory requirements and industry best practices.

Qualifications

• Current license to practice as an NP/PA in the state of MI.
• No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by FDA.
• At least 3 years of experience as a provider within the healthcare industry in the US, such as a clinic, hospital, ER or other medical office setting.
• Past or current experience as a Sub-Investigator in commercial clinical trials.
• Proficiency in procedures like EKG, phlebotomy, and injections/IVs.
• Experience with ordering labs and lab processing.
• Expertise in primary care, acute care, and chronic care practices.
• Knowledge of health and patient care regulations.
• Certified in BLS and/or Advanced Cardiac Life Support (ACLS).
• 2-3 years of experience conducting clinical trials (federal or commercial, experience in both is a bonus).
• Compliant with Good Clinical Practices (GCPs).

Candidate Traits

• Excellent clinical and communication skills.
• Able to make medical decisions in a fast-paced environment.
• Strong understanding of regulatory requirements, principles of Good Clinical Practice (GCP), and biomedical research ethics.
• Proficiency in electronic medical record systems and Microsoft Office Suite.
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity.
• Ability to manage multiple tasks and prioritize responsibilities.
• An established reputation for working well in a team environment and active in team building.
• Strong sense of commitment to reach objectives with a positive attitude despite challenges.
• Perform confidently under pressure.
• Work well under pressure and able to adapt to changes.
• Willingness to adapt, learn, and to continue gaining knowledge.

Salary and Benefits

The salary range is: $43.47 - $61.00/hr. Salary ranges will vary and are based on several factors, including geographic location, 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 SRI Benefits .