Clinical Research Coordinator

University of British Columbia - University of British Columbia (Vancouver campus), BC (30+ days ago)

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Staff - Non Union

Job Category
Non Union Technicians and Research Assistants

Job Profile
Non Union Salaried - Research Assistant /Technician 3

Job Title
Clinical Research Coordinator

Department
VGH Research Group Support Cardiology | Department of Medicine | Faculty of Medicine

Compensation Range
$3,905 - $4,612 CAD Monthly

Posting End Date
January 27, 2021

Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.

Job End Date

Nov 29, 2021

JOB SUMMARY

The Cardiology Research Coordinator is to support the activities related to the clinical research conducted by the research group based on complex technical tasks demonstrated by formal training and experience. This is a full time position.

ORGANIZATIONAL STATUS

Director of Research -> Investigator and Attending Cardiologists -> Research Manager -> Research Coordinator -> Research Assistants, Clerical Staff, Students

WORK PERFORMED

  • Maintains patient confidentiality.
  • Plans and performs experiments, utilizing complex procedures or techniques; troubleshoots problems; collects, records, analyses and interprets experiment results.
  • Assist in the planning, organizing and delivery of multiple concurrent clinical trials in accordance with study requirements and Good Clinical Practice (GCP). This includes assisting with: implementing study protocols; assisting in ethics submissions (renewals and amendments) and communicating and coordinating clinical trial activity with nursing staff, research team and representatives on PI's behalf.
  • Participating in developing and evaluating strategies to meet the clinical trial goals and objectives, overseeing project progress and ensuring enrolment expectations are met.
  • Implementing recruitment strategies, coordinating and conducting patient recruitment, identifying, screening, bookings and enrolling suitable patients into studies.
  • Developing tools to aid in protocol implementation including creating source documents and checklists, and designing case report forms and test worksheets.
  • Providing subject education on study background, purpose, procedures and potential benefits and risks.
  • Administers various study related questionnaires to subjects according to study protocol.
  • Collecting patient blood samples via venipuncture, processing and shipping samples as required.
  • Coordinating research subject treatment/tests with various departments, physicians and other study staff personnel.
  • Performing 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 train back-up study coordinator for vacation relief.
  • Carrying out research functions including checking and verifying patient history and medication use; obtaining records from patients' family physician, hospital or laboratory as required.
  • Ensuring 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.
  • Collecting, and entering research data into paper and electronic Case Report Form programs.
  • Coordinating and participating in meetings to inform the investigator and study staff of the clinical progress of the study subjects.
  • Reviewing data results and consult PI accordingly
  • Resolving any data related queries.
  • Assist in identifying and submitting to local Research Ethics Board (REB)
  • Informing investigator and sponsor of any Serious Adverse Events to patients during the trial.
  • Obtaining appropriate related data and follow up on Serious Adverse Events.
  • Acting as a key liaison with Principal Investigator (PI) and sponsors.
  • Managing study supplies, maintains inventory and is accountable to the PI, sponsor and federal regulatory bodies as per Good Clinical Practice guidelines.
  • Conducting the close out of the study ensuring proper storage according to regulatory requirements.
  • Meeting deadlines for study milestones.
  • Maintaining calibration records of study equipment and if needed schedule servicing and re-calibration of equipment.
CONSEQUENCE OF ERROR

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:

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

SUPERVISION RECEIVED

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

SUPERVISION GIVEN

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

Undergraduate degree in a relevant discipline or Graduation from a technical college or institute. Minimum of 3 years related experience or the equivalent combination of education and experience. Previous experience in clinical drug trials, computer skills, medical terminology. Previous experience in venipuncture is an asset. Self-directed and has the ability to exercise judgment and initiative. Team-oriented, committed and precise. Demonstrates responsibility and accountability. Good organizational and communication skills. Deal with a diversity of people in a calm, courteous and effective manner. Maintain accuracy and attention to detail. Ability to prioritize work effectively to meet deadlines. Work effectively independently and in a team environment. Ability to communicate effectively verbally and in writing. Ability to exercise tact, discretion and diplomacy. Ability to analyze problems, identify key information issues and effectively resolve the situation. The Clinical Research Coordinator is expected to work collaboratively as part of a team with other clinical research coordinators, hospital staff, attending physicians, support staff, grant and industry sponsors and their representatives, regulatory agents and clinical investigators.