Clinical Research Coordinator

6 days ago

Vaughan, Ontario, Canada BioPharma Services Inc., a HEALWELL AI Company Full time

Duties and Responsibilities:


• Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance with study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines.  Typically, the studies assigned will be complex Bioequivalence/Bioavailability studies and potentially assist with complex Phase 1 studies


• Review protocols and ICF


• Attend SIV meetings


• Generates Protocol and SOP deviations


• Conducts protocol/ logistics training for clinical research staff


• Performs compliance checks on subjects, as applicable


• Reports Adverse Events and Serious Adverse Events to appropriate department(s)


• Supervises, and assists in a drug administration


• Assists with appropriate control, and record keeping of study drug(s), as required


• Maintains study files for each clinical trial and performs a detailed review of documents prepared by Study Preparation Associates, including subject and study source documentation, and/or CRFs, as well as of completed Source Documents and CRFs


• Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements


• Ensures the accuracy of the generated data in accordance with protocols, ICH, GCP, and applicable regulatory agencies


• Maintains adequate, accurate, complete, and legible records


• Collaborates with QC and QA during audits and audit follow-ups


• Maintains current professional knowledge of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)


• Prepares reports- study update, BSTD, demo AE tale, SSU


• Follows up with subjects re: PSR, AES, unscheduled visits


• Performs other tasks, as assigned, and as training and experience allow

Qualifications:


• Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience


• Certification in Clinical Research is an asset


• Flexible hours depending on business requirements


• Weekend and evening requirements


• 3+ years' work experience in a CRO (preferably in conducting Bioequivalence/ Bioavailability clinical trials)


• Excellent problem solving, communication, multitasking and interpersonal skills


• Detail oriented


• Knowledge of Electronic Data Capture (EDC) systems is an asset.

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