Sub-Investigator/Advanced Practice Provider, Clinical Trials Research

Overview

SRI's Clinical Trials Unit is seeking an experienced Sub-Investigator (Sub-I)/Nurse Practitioner 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

This Role Is a Good Fit for a Nurse Practitioner Who:

• Is looking for flexible, project-based work rather than a traditional PT or FT schedule
• Wants research-focused work that is protocol-driven and structured
• Is available for pre-scheduled, on-site study visits, with advance notice whenever possible
• Is open to a mix of on-site and remote study-related work
• Values predictable expectations while maintaining control over their schedule
• Wants meaningful research involvement while balancing family, personal, or other professional commitments
• Is dependable, responsive, and comfortable supporting studies as needs arise

 

Estimated Time Commitment:

• Flexible, study-driven hours that vary week to week
• Time commitment may be lighter at first, with an average of up to ~4–8 hours per week initially, and the potential to grow to ~8–16 hours per week as studies expand
• Some weeks may be lighter, while others may be busier depending on visit schedules
• On-site time scheduled in advance for study visits, with some work able to be completed remotely

 

As our clinical research portfolio continues to grow, there may be an opportunity for this role to transition into a more regular part-time or full-time position in the future, should there be mutual interest.

 

Key Responsibilities include:

• 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

Required:

 

• Current license to practice as an Nurse Practitioner 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 t