Principal Investigator at Centricity Research
Levis, Quebec, Canada -
Full Time


Start Date

Immediate

Expiry Date

17 Apr, 26

Salary

0.0

Posted On

17 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Clinical Trials, GCP Compliance, Study Protocols, Medical Oversight, Informed Consent, Regulatory Compliance, Study Records Management, Participant Safety, Training and Supervision, Ethics, Investigational Products, Risk Reporting, Financial Disclosure, ACLS Certification, Research Experience, MD or NP License

Industry

Biotechnology Research

Description
Job Details Job Location: Levis, QC G6W 0M5 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 Qualifications
Responsibilities
The Principal Investigator is responsible for the conduct of clinical trials, ensuring participant safety and data integrity. They oversee compliance with regulations and manage the study's medical decisions.
Loading...