Clinical Research Coord 3 (CRC 3) - BioPharma Services Inc.

Duties And ResponsibilitiesCoordinates, 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 studiesReview protocols and ICFAttend SIV meetingsGenerates Protocol and SOP deviationsConducts protocol/ logistics training for clinical research staffPerforms compliance checks on subjects, as applicableReports Adverse Events and Serious Adverse Events to appropriate department(s)Supervises, and assists in a drug administrationAssists with appropriate control, and record keeping of study drug(s), as requiredMaintains 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 requirementsEnsures the accuracy of the generated data in accordance with protocols, ICH, GCP, and applicable regulatory agenciesMaintains adequate, accurate, complete, and legible recordsCollaborates 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, SSUFollows up with subjects re: PSR, AES, unscheduled visitsPerforms other tasks, as assigned, and as training and experience allowQualificationsCompleted postsecondary degree in a science or healthcare related discipline, or equivalent work experienceCertification in Clinical Research is an assetFlexible hours depending on business requirementsWeekend and evening requirements3+ years’ work experience in a CRO (preferably in conducting Bioequivalence/ Bioavailability clinical trials)Excellent problem solving, communication, multitasking and interpersonal skills Detail orientedKnowledge of Electronic Data Capture (EDC) systems is an asset.PI279819071