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Guide to physician roles in clinical research operations, including principal investigator and site management positions.
Clinical research operations involves conducting clinical trials at research sites. Physicians serve as Principal Investigators (PIs) or Sub-Investigators (Sub-Is), directly overseeing patient enrollment and study procedures.
Serve as Principal Investigator for clinical trials
Oversee patient screening, enrollment, and study visits
Ensure protocol compliance and patient safety
Manage relationships with sponsors and CROs
Lead research site staff (coordinators, nurses)
Report adverse events and manage safety
Principal Investigator
Sub-Investigator
Medical Director, Clinical Research
Research Physician
Site Medical Director
Required:
MD with active medical license
GCP (Good Clinical Practice) certification
Ability to enroll and manage patients
Strong documentation skills
Preferred:
Prior clinical trial experience
Board certification
Established patient population
Research site management experience
Part-time PI work: $100 - $300 per patient visit
Full-time research physician: $200,000 - $350,000
Medical Director: $250,000 - $400,000
Dedicated research sites and site-management organizations (SMOs)
Academic medical centers and hospital-based research units
Private practices that host trials alongside routine clinical care
Contract research organizations (CROs) and sponsor-operated sites
Complete GCP training: Good Clinical Practice certification is the baseline credential sponsors expect before you can serve on a trial.
Start as a Sub-Investigator: Working under an experienced PI is the most common on-ramp before taking on the Principal Investigator role yourself.
Leverage your patient population: Sites are selected partly on their ability to enroll, so an established panel of eligible patients is a genuine asset.
Learn the regulatory framework: Comfort with IRB submissions, informed consent, delegation logs, and FDA Form 1572 obligations makes you a credible investigator.
Clinical research operations suits physicians who want to stay close to patients and clinical medicine while contributing to the evidence base. Many start with part-time PI work layered onto an existing practice, then scale up as their site's trial portfolio grows. The work rewards meticulous documentation, comfort operating within a protocol, and the ability to lead a coordinated site team of coordinators and research nurses.
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