Part Time PRN Sub Investigator - MD/DO General Medicine
Job Description
Job Description
Summary
The Sub-Investigator (Sub-I) plays a vital role in clinical research by supporting the Principal Investigator (PI) in the conduct of clinical trials. This is a part-time, on-site position (approximately 8–10 hours per week) and offers an excellent opportunity for professional growth, with a clear path to advance into a Principal Investigator role.
We are seeking a research-minded physician with a passion for patient-centric care and strong aptitude of learning within clinical research.
Duties and Responsibilities: The Sub-Investigator:
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Assess study feasibility and ability to deliver on enrollment in consultation with Site Director
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Attends Site Initiation Visits (SIVs), study feasibility visits, investigator meetings, and required protocol training as applicable.
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Performs and/or reviews required medical assessments, including physical exams, neurological exams, ECGs, laboratory results, imaging, and drug/toxicology tests.
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Assesses adverse events for severity, seriousness, and causality in collaboration with the PI.
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Assists the PI with review and reporting of serious adverse events (SAEs) as needed.
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Reviews medical history, concomitant medications, and clinically relevant findings as part of eligibility and ongoing safety oversight.
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Reviews and confirms subject eligibility for study participation.
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Performs medical and oversight responsibilities delegated by the PI per protocol and regulatory requirements.
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Provides medical guidance and clinical oversight to the research team as needed.
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Maintains familiarity with site SOPs and protocol requirements relevant to physician oversight.
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Supports training and supervision of clinical staff related to medical assessments and protocol conduct.
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Collaborates with the study team and study monitors regarding subject eligibility, safety, and protocol adherence.
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Maintains availability to evaluate subjects onsite and/or remotely as required by study visits; scheduling is coordinated in advance.
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Conducts or oversees the informed consent process when applicable, ensuring subject understanding and use of the current approved ICF following local SOPs
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Reviews source documentation and signs off on medical assessments and charts as required.
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Reviews study data and responds to clinical questions or data clarifications related to medical assessments.
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Ensures subject safety and provides medical judgment regarding continuation, withdrawal, or referral for outside medical care when appropriate.
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Participates in study-related meetings as needed.
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Reviews and maintains familiarity with the Investigator’s Brochure (IB), including known risks and safety information.
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Occasional travel to investigator meetings or company-sponsored meetings, as applicable.
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Performs other physician-level duties related to study oversight as assigned by the PI or medical leadership.
Competency Requirements:
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Strong clinical judgment and decision-making skills
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Clear and effective communication with clinical staff and monitors
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Ability to work collaboratively within a multidisciplinary research team
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Attention to subject safety, protocol compliance, and data integrity
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Adaptability in a fast-paced research environment
Physical Requirements and Environmental Factors:
- Mid-level computer use
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Patient-facing interaction and record/result trend review and tracking
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Work is normally performed in a typical interior clinical/office environment.
- Prolonged periods of sitting at a desk and working on a computer.
- Lifting of 20 pounds and occasionally more than 20 pounds.
