The physician works closely with the qualified investigator to manage and oversee subject safety during screening, during the conduct of clinical studies and for the post-study follow up of Bioequivalence and Phase 1 clinical trials in compliance with clinical research regulations.
• Ensure subject safety at all times during the clinical study and after the study has been completed as required by the protocol and GCP and GLP regulations.
• Review study protocols to acquire in-depth knowledge of the protocol.
• Assist the Qualified Investigator in all duties regarding the safe conduct of clinical research.
• Carry out the full spectrum of medical activities related to subject eligibility for studies (medical exam, laboratory results, electrocardiogram assessment,...) so that inclusion and exclusion criteria are respected (pre-study).
• Perform follow-up and ensure the quality of information related to subject eligibility.
• Responsible for on-study supervision and works closely with clinical research staff.
• Perform all required clinical exams as per the study protocol.
• Assess adverse events and carry out the appropriate medical judgement, and follows-up to determine the resolution of adverse events.
• Interact with clients for onsite visits to address any safety concerns/questions.
• Participate in on-call coverage requirements.
• May be called upon to perform other duties as required.
May be assigned other clinical tasks
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permane nt representation.
• Doctorate in medicine
Relative alternate certification may be considered acceptable.
This determination ensures the jobholder has sufficient technical ability to perform the role.
• Ability to work in a team with a wide variety of clinical positions.
• Strong documentation skills with a focus on attention to detail.
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Advanced Cardiac Life Support certification or equivalent. Must be certified or recertified to conduct study monitoring or have equivalent documented experience. (Training offered in-House).
• Knowledge of GCP/ICH guidelines and other applicable regulatory requirement
• Experience within a client-service environment.
• In-depth understanding and knowledge of the pharmaceutical industry and contract research organizations in general, and the clinical community specifically
Position in Canada:
• English level: Required English proficiency includes being able to communicate verbally on subjects that are frequently specialized and technical, and writing complex technical reports
• Active membership of the CMQ.
Other (optional): Candidate who does not possess the required training and/or experience may be considered under different criteria.