Clinical Trials Specialist

2 months ago

Vancouver, British Columbia, Canada The University of British Columbia Full time
Job Summary

The University of British Columbia is seeking a highly skilled and detail-oriented Research Coordinator to support the activities related to clinical research conducted by the research group. This is a 1.0 FTE position.

Key Responsibilities
  • Maintains patient confidentiality and adheres to regulatory guidelines and approvals.
  • Plans and performs experiments, utilizing complex procedures or techniques; troubleshoots problems; collects, records, analyses and interprets experiment results.
  • Assists in the planning, organizing and delivery of multiple concurrent clinical trials in accordance with study requirements and Good Clinical Practice (GCP).
  • Participates in developing and evaluating strategies to meet the clinical trial goals and objectives, overseeing project progress and ensuring enrolment expectations are met.
  • Implements recruitment strategies; coordinates and conducts patient recruitment into suitable studies.
  • Develops tools to aid in protocol implementation including creating source documents and checklists, and designing case report forms and test worksheets.
  • Provides subject education on study background, purpose, procedures and potential benefits and risks.
  • Administers various study-related questionnaires to subjects according to study protocol.
  • Collects patient blood samples via venipuncture, processing and shipping samples as required.
  • Coordinates research subject treatment/tests with various departments, physicians and other study staff personnel.
  • Performs tests relevant to training such as ECG, stress test, Holter and blood pressure.
  • Assists senior level staff with the design of experiments and/or development of new techniques for laboratories or facilities and trains back-up study coordinator for vacation relief.
  • Carries out research functions including checking and verifying patient history and medication use; obtaining records from patients' family physician, hospital or laboratory as required.
  • Ensures appropriate notification to family physicians and/or specialists of patient's participation and of any change in patient's condition or abnormal test results and action taken by PI.
  • Collects and enters research data into paper and electronic Case Report Form programs.
  • Coordinates and participates in meetings to inform the investigator and study staff of the clinical progress of the study subjects.
  • Reviews data results and consults PI accordingly.
  • Resolves any data-related queries.
  • Assists in identifying and submitting to local Research Ethics Board (REB).
  • Informs investigator and sponsor of any Serious Adverse Events to patients during the trial.
  • Obtains appropriate related data and follow-up on Serious Adverse Events.
  • Acts as a key liaison with Principal Investigator (PI) and sponsors.
  • Manages study supplies, maintains inventory and is accountable to the PI, sponsor and federal regulatory bodies as per Good Clinical Practice guidelines.
  • Conducts the close-out of the study ensuring proper storage according to regulatory requirements.
  • Meets deadlines for study milestones.
  • Maintains calibration records of study equipment and if needed schedules servicing and re-calibration of equipment.
Consequence of Error/Judgement

Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/university as a site for further clinical research and/or funding. Clinical mistakes made by the coordinator could be potentially affect safety of the subjects. PI relies on the coordinator to alert them to clinical problems and unexpected events concerning study subject and trial conduct. Failure to do so may result in patient's safety being jeopardized. The performance of clinical trials and research projects must strictly conform to appropriate regulations:

  • Personal: maintaining professional behavior and respect for patients and staff
  • Local: the UBC Clinical Research Ethics Board
  • Provincial: BC Privacy Act
  • Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice
  • International: US Food & Drug Administration
Supervision and Accountability

The Research Coordinator works under minimum supervision and collaborates with Research staff, reporting to the Research Manager, Investigators, and Director.

The Research Coordinator provides supervision to students when appropriate; acts as a resource with hospital staff, patients and colleagues; and manages the conduct of patient progress and follow-up.

Qualifications

Completion of a relevant technical program or a university degree in a relevant discipline and a minimum three years of related experience or an equivalent combination of education and experience.

Willingness to respect diverse perspectives, including perspectives in conflict with one's own.

Demonstrates a commitment to enhancing one's own awareness, knowledge, and skills related to equity, diversity, and inclusion.

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