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
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