Clinical Research Coord 3

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.

PI