Principal Investigator
Job Category:
Part time (30 hours per week) including the benefits of the company.
Job description:
In an environment of clinical research, as a Principal Investigator, you will need to do:
- To ensure that a clinical trial is conducted in accordance with protocol requirements to protect the safety, the rights or the welfare of subjects.
- To ensure that subjects are adequately informed about the drugs under investigation.
- To participate in writing or review of SOPs related to the medical sector activities or subject’s safety.
- To evaluate the screening records and decide on the eligibility of a volunteer to participate in a trial.
- To report to the sponsor all adverse experiences that occurs during the course of the investigation.
- To ensure that clinicians (or sub-investigators) are trained and informed about their obligations, about the protocol, GCPs and SOP requirements and trial-related duties and functions.
- To ensure that the subject's health and safety are adequately secured at all times. This includes the accurate choice of biomedical laboratory tests or other tests necessary to adequately qualify participating subjects, and the use of vital signs, ECGs or other safety tests to be performed after drug administration.
Qualifications:
Education: Physician registered to the Collège des Médecins du Québec and qualified by training and/or experience as experts to investigate the drug under investigation. In depth knowledge of FDA-GCP and TPP regulations pertaining to safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers and in depth knowledge of federal and provincial regulations regarding the medical act and nursing care are required.
Skills: Bilingual (both written and verbal in French & English). The Principal Investigator is deemed competent when he/she reads and understands the available information on the product under investigation, including the potential risks and side effects of the drug.
Software: MS Office Suite