Clinical Research Coordinator

 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 allowQualifications:• 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.