Principal Investigator

POSITION FUNCTION

The Principal investigator (PI) is responsible for the conduct of the clinical trial at a trial site. The PI is responsible for the safety of the study participants, management and integrity of the study conduct and data collected in the clinical study. Also, to ensure the study is conducted in compliance with GCP, federal regulations, ethics, the company SOPs, and the study protocol.

ESSENTIAL FUNCTIONS

• Ensure the safety and welfare of study participants

• Supervising the conduct of the clinical research study even when responsibilities have been delegated to other appropriately trained and qualified staff members

• Responsible for the oversight of all trial-related medical decisions as outlined in FDA 1572 and/or HC QIU

• Ensuring compliance with regulatory body regulations, GCP, ethics, SOPs and the sponsor protocol

• Ensuring all staff delegated are experienced and have sufficient documented training

• Demonstrate potential for enrollment of subjects and following appropriate informed consent procedures as outlined in ICH & regulatory body regulations

• Protecting the rights, safety and welfare of subjects enrolled in a clinical research trial

• Familiarity with the appropriate use of the investigational product(s) as described in the protocol, in the current Investigator's Brochure, in the product monograph and in other information sources provided by the sponsor

• Maintaining adequate study records and storage as per regulatory requirements

• Maintaining appropriate control, inventory, distribution, storage, record keeping and destruction or return of test articles

• Promptly reporting to sponsor, IRB or Regulatory agencies as applicable any unanticipated problems & risks to patients

• Ensuring timely reporting to the ethics of all events that require prompt reporting such as annual progress reports or major protocol deviations

• Assuring the disclosure of financial interest and arrangements to the sponsor and the REB
  

EDUCATION/EXPERIENCE

Minimum:

• MD or NP

• Licensed to practice in Quebec

• In good standing for practice

Preferred:

• At least 1-5 years of research experience

• ACLS Certified is preferred