Careers

Position Title: Clinical Trial Principal Investigator

Reports To: Site Principal Investigator

Date Prepared: November 08, 2022

Purpose of Position: To carry out Principal Investigator responsibilities with respect to clinical trial protocols.

Key Accountabilities

1. Investigator Qualifications
   • Maintain up-to-date curriculum vitae which reflects the requisite education, training and certifications to act as a clinical trial investigator
   • Maintain current licensure to practice as an MD in Ontario
   • Provide the sponsor and research ethics board (REB) with documentation of credentials as requested
   • Disclose conflicts of interest
   • Follow ICH-GCP, FDA CFR, Health Canada Division 5 guidelines, and TMP SOPs
   • Work collaboratively with the entire research team
   • Attend investigator meetings, site initiation meetings, and internal research meetings as assigned
2. Ensure Protocol Compliance:
   • Possess a thorough understanding of the requirements of each clinical trial protocol
   • Avoid protocol deviations or making any changes to protocol activities without agreement by the sponsor and prior review and approval by the REB (except to eliminate immediate hazard to the patient)
3. Manage the Medical Care of the Research Subjects:
   • Possess familiarity with each clinical trial Investigator Brochure
   • Assess patient compliance with protocol activities and study drug
   • Evaluate and document adverse events
   • Ensure provision of medical care and follow up as needed for  adverse events
   • Inform the subject’s primary care physician of their participation in a clinical trial and of adverse events unless the subject declines consent for the investigator to communicate with the primary care physician
   • Communicate in a timely manner with the medical monitor assigned by the sponsor to respond to and resolve any safety or eligibility concerns
4. Protect the Rights and Welfare of Patients
   • Report all serious adverse events and adverse events of special interest to the sponsor within 24 hours and to the  REB when the event meets the REB’s reporting requirements
   • Obtain a signed and dated informed consent form from the patient or patient’s legally authorized representative (LAR) prior to initiating any study-related procedures
   • Assess and determine subject’s mental capacity for informed consent
   • Ensure subject assent if subject is incapable of consent
   • Inform the patient and/or LAR about all aspects of the clinical trial
   • Provide new information about the study or study drug as it becomes available
5. Ensure Documentation of Study-Related Procedures, Processes and Events:
   • Document deviations from the approved protocol
   • Cooperate with site PI in the development of corrective and preventative action plans (CAPAs) as needed
   • Document the informed consent process
   • Document all adverse experiences with respect to AE term, causality, seriousness, and management
   • Comply with written procedures to document changes to data and/or case report forms
   • Author formal progress notes at Screen and Randomization visits and at other key junctures in the course of a subject’s trial participation
6. Ensures the Proper Use and Storage of Investigational Product:
   • Be familiar with the use of the investigational product
   • Be familiar with the Investigators Brochure, product insert, and other sources  of information regarding the study drug
7. Clinical Care
   • As part of recruitment initiatives and in conjunction with staff physicians, assess, diagnose and treat patients with neurological disorders.

Job requirements

Competencies:

• Strong communication skills
• Effective leadership skills
• Excellent interpersonal skills: Able to interact with professional, administrative staff, sponsor and regulatory representatives and patients

Minimum Qualifications:

• Minimum of one year experience as a Principal Investigator or minimum of three years of experience as a Sub-Investigator in clinical trials.
• Thorough understanding of regulatory requirements
• Licensed, or eligible for license, to practice in the Province of Ontario.