Sub-Investigator/Advanced Practice Provider, Clinical Trials Research

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.
• 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.
• 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.

Requirements

• 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 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).

Key Skills

• 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.
• A strong sense of commitment to reach objectives with a positive attitude despite challenges.
• Willingness to adapt, learn, and to continue gaining knowledge.

Benefits

To view details of SRI's benefits package, please visit here.