Toronto, Ontario – Supervisor, Clinical Research

Reports to: VP Global Clinical Operations

Position Summary:

Oversee conduct of clinical research studies at BioPharma Services Inc. ensuring compliance with study protocol, SOPs, GCPs and regulatory requirements as well as adherence to the assigned timelines.

Lead and coach Clinical Research Coordinators to ensure proper planning, organization and execution of clinical research studies.

Coordinate and mange Phase I studies in accordance with the protocol, Sops, GCP guidelines, and applicable regulations, providing guidance and directions to clinic staff.

Duties and Responsibilities:

  • Supervises and schedules CRC, CRCA and Study Preparation Associates and oversees planning and hiring activities, performance evaluations and routine monitoring of productivity
  • Facilitates knowledge development; oversees, organizes and conducts CRC, CRCA and Study Preparation Associates training as appropriate
  • Ensures efficiency and mobilization of the Clinical Research staff to achieve expected results
  • Establishes and maintains quality standards for the CRC, CRCA and Study Preparation Associates and ensures adherence to study protocols, BPSI SOPs, Directives, and ICH-GCPs guidelines and regulatory requirements
  • Participates in project scheduling, establishing relevant project timelines and serves as a key interface with Project Management with regard to budget, resource allocation, priorities, strategy, and time lines.
  • Contributes to all clinical development activities from program development to submission
  • Provides input to the Clinic calendar
  • Meets and addresses issues with study monitors, sponsors and regulatory agencies as required
  • Participates in review and development of study protocols, BPSI SOPs, and internal procedures
  • Oversees, coordinates, monitors and supervises execution of bioequivalence (BE), Phase I, etc., clinical research trials to ensure study protocol, BPSI SOPs and policies/Directives, ICH-GCP and regulatory requirements are met
  • Assists CRC, CRCA and Study Preparation staff in addressing study related issues
  • Analyzes and develops action plans to address QA findings, including development of CAPA reports
  • Schedules CRC, CRCA and Study Preparation Associates
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Maintains adequate, accurate, complete and legible records
  • Provides input to the clinic calendar, assists Senior Management with daily operations as required
  • Performs CRC, CRCA and Study Preparation Associates or other duties if required and as training and experience allow

Qualifications:

  • Completed post-secondary 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
  • 3+ years’ work experience in a CRO (preferably in conducting Phase 1/Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel

Please send your resume to resumes@biopharmaservices.com