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Clinical Research Associate at Clinical Development Solutions Inc

Ontario, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

23 Nov, 26

Salary

0.0

Posted On

25 Aug, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Hospitals & Health Systems

Description

Duties and Responsibilities:May conduct pre-study site assessment/qualification visits, collection and review essential documents, prepare evaluative reports; participate in the final selection of investigators and study sites and participate in study start-up activities.
May conduct site initiation visits; advise and train site personnel on sponsor and regulatory requirements for study; participate in site meetings and multi-centre investigator meetings and prepare visit reports.
Site Management Activities, including maintain all essential clinical documents and manage supply of investigational product throughout the trials
Conduct site monitoring visits and follow-up on any outstanding issues; ensure all clinical aspects of the studies are being carried out in accordance with the clinical protocol, ICH GCP, state/provincial and federal/country regulations, guidelines and policies; and prepare site status reports and monitoring visit reports.
Review site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies; and provide remedial training and/or initiate corrective action as required.
May conduct investigator site close-out visits and assist in the termination of clinical studies by identifying items and issues for review and/or follow-up; collection of necessary documents, reconciliation of study drug/device and disposition, review of completeness and accuracy of files, retrieval of relevant codes, prepare study close-out / termination reports.
Assist in the reconciliation of and follow up on adverse event reporting, and serious adverse event reporting to ensure appropriate notification and compliance with regulatory agency, IRB/REB and SOPs
May assist sites with preparation for regulatory agency, sponsor, or IRB/REB audits.
Current projects are local (Winnipeg). Future projects may involve travel within Canada & USA up to 60%.
May perform other miscellaneous job-related duties as assigned.

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Responsibilities