Principal Investigator
Toronto / Greater Toronto Area

MPA are retained by a Toronto based CRO to recruit for a Principal Investigator to join their team. The CRO run early-phase studies, bioequivalence testing, validate new drugs and provide regulatory support for pharmaceutical companies.

In this role, you will uphold Good Clinical Practice (GCP) by ensuring protocol compliance, protecting participant welfare, maintaining data integrity, and overseeing clinical investigations in line with regulatory requirements.

Duties and Responsibilities:

• Conduct clinical trials in accordance with the approved protocol, including any amendments, as well as all study procedures and directives
• Protect the rights, safety, and well-being of all participants, ensuring appropriate medical care throughout their involvement in the trial
• Maintain thorough knowledge of investigational product(s) as outlined in the protocol, Investigator’s Brochure, and product monograph, and provide clear instructions to participants on proper use
• Adhere to study randomization procedures and promptly document and report any premature unblinding to the sponsor and IRB, where applicable
• Obtain and properly document informed consent in compliance with all regulatory and ethical requirements
• Report all Serious Adverse Events (SAEs) and pregnancy notifications to the sponsor and IRB in a timely manner
• Assess participant eligibility and ongoing health status, including medical history, inclusion/exclusion criteria, laboratory results, vital signs, adverse events, and study-specific procedures
• Evaluate adverse events for causality, severity, and outcome, and recommend follow-up actions, including repeat testing when clinically indicated
• Perform physical examinations of study participants
• Confirm participant eligibility for investigational product administration
• Follow up on clinically significant findings, including positive infectious disease results and notify appropriate health authorities as required
• Ensure site compliance with Good Clinical Practice (GCP), standard operating procedures (SOPs), and applicable regulatory requirements
• Review and sign clinical trial protocols, clinical study reports, and case report forms (as applicable), and participate in safety data reviews when required
• Maintain accurate, complete, and legible study records, ensuring availability for review by monitors, auditors, and regulatory authorities.

Qualifications:

• Medical Doctor (M.D.) degree
• Registered and in good standing with CPSO.
• Minimum of 5 years of experience in clinical research
• At least 8 years of experience in drug development and clinical trial administration, with active clinical practice in a relevant therapeutic area
• Demonstrated ability to adapt to changing priorities and manage multiple projects effectively
• Advanced and up-to-date knowledge of:
  • Clinical trials and study design
  • Drug development processes
  • Medical monitoring
  • Applicable federal and international regulations and guidelines
• Familiarity with medical coding systems and adverse event review/reporting processes is considered an asset

Strong compensation package on offer. If this opportunity would be of interest to you, please reach out to james.mcnamee@mparecruitment.ca for a confidential chat.