Clinical Research Coordinator

at  BIOPHARMA SERVICES INC

Duties and Responsibilities:

• Coordinates, executes, and monitors all study activities to ensure the conduct of clinical trials in accordance with the study protocol, BPSI SOPs and/or Directives, ICH-GCPs, and applicable regulatory guidelines. Typically, the studies assigned will be more complex Phase 1 studies.
• Liaise with the study sponsor during the planning process and protocol development to ensure BPSI understands and has planned to meet their expectations. Project lead for all clinical aspects of the studies assigned. This includes providing reasonable timelines to internal clients (such as Quality Control, Quality Assurance, Project Management and Data Management) and external clients.
• Conducts protocol training for clinical research staff
• Performs compliance checks on subjects as applicable
• Reports Adverse Events and Serious Adverse Events to appropriate department(s)
• Supervises, administers and/or assists in a drug administration
• Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
• Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates 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 base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
• Participate in staff training sessions
• 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

• Coordinates, executes, and monitors all study activities to ensure the conduct of clinical trials in accordance with the study protocol, BPSI SOPs and/or Directives, ICH-GCPs, and applicable regulatory guidelines. Typically, the studies assigned will be more complex Phase 1 studies.
• Liaise with the study sponsor during the planning process and protocol development to ensure BPSI understands and has planned to meet their expectations. Project lead for all clinical aspects of the studies assigned. This includes providing reasonable timelines to internal clients (such as Quality Control, Quality Assurance, Project Management and Data Management) and external clients.
• Conducts protocol training for clinical research staff
• Performs compliance checks on subjects as applicable
• Reports Adverse Events and Serious Adverse Events to appropriate department(s)
• Supervises, administers and/or assists in a drug administration
• Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
• Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates 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 base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
• Participate in staff training sessions
• Performs other tasks as assigned and as training and experience allo