Job Description - Clinical Research Scientist (20006547)
Clinical Research Scientist-(20006547)
The Clinical Research Scientist is responsible for collecting and synthesizing scientific information in order to prepare clinical study records in accordance with regulations, customer requirements and ethical standards as well as obtaining applicable regulatory approvals. Also acts, as a resource person in his/her scientific field for clients and other divisions.
•Act as a scientific consultant to clients and provide scientific and regulatory support to other company divisions.
•Actively participate in regulatory monitoring; prepare, revise and update the scientific database (ex.: Scientia) used by other divisions.
•Participate, along with members of each division implicated in the project, in reviewing Phase I protocols prepared by clients.
oProvide scientific support to the client regarding study design.
oPrepare and oversee the quality control of informed consent forms when required.
oKeep track of the documents until the end of the clinical portion of the study.
•Plan and carry out all bioequivalence and phase I study protocol writing and quality control activities as well as all related documents.
oEnsure that the study design is adequate and meet study objectives all the while ensuring subject safety.
oSuggest and justify appropriate changes to the client, when required.
oKeep track, within established timelines, of the protocol and related documents from their writing up until the end of the clinical portion of the study.
oSynthesize and integrate into the documents the comments made by the client, internal stakeholders, the ethics committee and regulatory agencies (pre and post study).
•Prepare, review and submit bioequivalence clinical trial applications for approval by Health Canada and perform the necessary monitoring to ensure that all regulatory requirements to begin a study are met.
•Communicate with regulatory agencies to ensure the feasibility and compliance of clinical trial applications at the regulatory level.
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 permanent representation.
Master’s degree in Science
Relative alternate certification may be considered acceptable.
This determination ensures the jobholder has sufficient technical ability to perform the role.
•2 years of relevant work experience would be considered an asset.
•Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and Acrobat software.
•Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
•Experience in regulatory context will be considered an asset
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Application from outside Canada
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