May 12, 2022 at 9:00 am #29788
Nature of the work
Reporting to Dr. Aneal Khan, the Clinical Research Coordinator will play a vital role in the success of Metabolic Diseases Research.
This position will be located at the M.A.G.I.C. Clinic LTD and will support the principal investigator(s) with clinical trials in multiple therapeutic areas working with a variety of protocols. Work will be performed mostly offsite but this position will be required to attend in person for certain study procedures as necessary at various sites.
The Clinical Research Coordinator may be required to travel to clinical locations within the city in order to support the needs of the principal investigators involved in clinical trials.
The purpose of visiting investigational and training sites (at the discretion of the Principal Investigator; inside/outside the country) is to verify the protocol requirements are being adhered to, to receive training, to attend study meetings and/or to present experience with study conduct, procedures and regulations.
Primary Purpose of the Position:
The successful candidate is a Clinical Research Professional who functions as a leader, administrator, coordinator, consultant, educator and researcher and is responsible for the case management of multiple Clinical Trials and participants and related documentation, and booking travel for patients. This role requires in depth knowledge of data collection, monitoring, case management of protocol participants, participant recruitment and enrolment, and protection of participants and participant’s rights according to all relevant regulatory guidlines, such as the Tri-Council Policy Statement II and the International Conference on Harmonization ICH/GCP guidelines.
5-7 years of experience in an Active Clinical Trials Setting/Role with preference to experience of cell transplantation and/or other Phase I trials
Evidence of Ongoing Clinical Trials education and professional growth
Proof of Professional Designation (SoCRA or ACRP) is mandatory
Knowledge of ICF/GCP Guidelines Knowledge Health Canada Regulations
General knowledge of FDA Regulations
Knowledge of EMA Regulations an asset
Ability to multi-task and priorities multiple tasks
Strong interpersonal initiative and teamwork
Demonstrated time management and organizational skills
Excellent verbal and communication skills
Bachelor degree required
Experience with CTAs and clinical trials with Health Canada
Experience about drug sponsor audits
Experience with clinical trial vendor programs, i.e. RAVE, IVRS, Greenphire etc.
Experience writing ethics submissions
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