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JOB DESCRIPTION

Insight Global is hiring a Principal Investigator responsible for ensuring Good Clinical Practice (GCP) in the conduct of clinical investigations and full compliance with protocols, regulations, and guidance documents. This role oversees all medical and safety-related activities for clinical research studies under IRB-approved protocols, protecting subject rights and ensuring data integrity. The Principal Investigator will lead, train, supervise, and delegate to a multidisciplinary team of physicians, physician assistants, nurse practitioners, and Sub‑Investigators. Responsibilities include providing medical oversight, protocol feasibility input, SOP and safety procedure development, and consultation throughout study execution. The role involves direct sponsor engagement, including capability presentations, bid defense meetings, and review of clinical trial protocols and study reports. The Principal Investigator will assess subject eligibility, perform physical examinations, review medical histories and laboratory results, and obtain and document informed consent. They are accountable for evaluating, documenting, and reporting adverse events, serious adverse events, pregnancies,



and clinically significant findings to sponsors, IRBs, and applicable authorities. Maintaining accurate, complete, and inspection-ready records, including case report forms and safety data, is essential to the success of this position.

REQUIRED SKILLS AND EXPERIENCE

• Valid MD license, with the ability to practice in Ontario • Positive standing with CPSO, CMPA or equivalent coverage • BCLS/ACLS certification under AHA. • Experience conducting phase I-II trials and BA/BE studies. • 8-12 years of experience in clinical research. • 8-12 years of drug development and clinical trial administration • Knowledge Federal and/or international guidelines and regulations,

NICE TO HAVE SKILLS AND EXPERIENCE

Ability to be flexible and adapt to and manage constant changes in priorities and projects. • Expert and up to date knowledge of: o Clinical trials, o Drug development, o Medical monitoring experience, o Knowledge of medical coding and systems for adverse event review and reporting is preferred, and, o Pharmacokinetics.

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📌 Principal Investigator (Toronto)
🏢 Insight Global
📍 Toronto