Clinical Research Coordinator 3 (CRC3)
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