Clinical Research Co-ordinator

Position Description: Job Title: Clinical Research Coordinator Location: Providence Health Care

**Faculty**: Medicine

**Department**:Medicine

**Division**:Cardiology

**Position Summary**:

- The Clinical Research Coordinator’s primary responsibility is to plan, coordinate, implement and evaluate the conduct of clinical trial initiatives focused on supporting the UBC division of Interventional Cardiology Research.
- The coordinator will work closely with patients and their families and other health care professionals utilizing medical protocols for the management of cardiovascular and cardiac disease and its complications with support by cardiovascular clinicians.
- These studies include: investigation of new drugs, investigation of new devices, evaluation of new treatment regimens, comparison of treatment strategies, and epidemiology of clinical events or interventions. The studies vary in scope from small and confined to SPH to large, international and multicentred.

**Organizational Status**:
The Coordinator reports to the Research Manager, Principal Investigator, and Director of Interventional Cardiology Research. This position requires working both independently and in cooperation with hospital nursing management and staff, cardiac catheterization laboratory staff clinical laboratory and pharmacy staff, study centre staff, and representatives of industry.

**Work Performed**:

- Responsible for planning, coordinating, implementing and evaluating the conduct of clinical trial initiatives within the UBC division of Interventional Cardiology Research
- Identifies and troubleshoots clinical questions or problems which affect patient care and provides leadership in resolving the situation. All unresolved issues are referred to the study-appointed cardiologists or other clinician-scientists
- Responsible for budget development and preparation
- Administers protocol deviations and adverse events
- Oversees and coordinates data and specimen transfer
- Administering study agent and/or supplying appropriate device
- Conducts preliminary data analysis on study data bases
- Generates progress and interim reports for presentation
- Prepares and follows up on initiatives or issues relating to research and clinical trials
- Provides leadership in all areas of research and clinical trials in the hospital and community
- Teaches and provides leadership to staff in associated areas within the hospital regarding the study purpose, goals, objectives and requirements
- Independently evaluates eligible patients for study entry
- Obtains and documents patient informed consent as per GCP (Good Clinical Practice)
- Informs investigator, sponsor and UBC/PHC Clinical Research Ethics Board of any Serious Adverse Events to patients during the trial
- Case management of ongoing follow-up assessment including history, physical exam
- Completing and correcting study records and case report forms independently or in consultation with the sponsor
- Oversee completion and confidentiality of the study including audits by sponsor and/or regulatory authority
- Supervise patient progress and follow-up.

**Decision making/Level of accountability**
- Exercises judgment and discretion to provide leadership and resolve problems
- Accountable for the accuracy and reliability of their work.

**Consequence of Error/Impact of Decisions**:
Judgment and impact of decisions involved in the position scopes a number of areas:

- Conducting trials according to standards set out by the ethics committee and standards of the ethics and international guidelines regulating the conduct of clinical trials. Dismissal would result if ethical standards were not followed.
- Conduct trials according to the budget or bankrupting the department would result
- Failure to inform the investigators of appropriate clinical issues of a patient may result in the failure to maintain patient safety

If any of these situations were to occur, clinical trials may be unable to proceed within the institution.

**Supervision Received**:
The Coordinator may be responsible for 4-15 studies which are performed independently on a daily basis with reporting at research meetings and/or discussions with Manager and Investigator on a weekly basis. These studies may involve many different geographical areas including hospital wards, laboratories and physician offices as well as out-patient clinics.

**Supervision Given**:
The Coordinator advises research assistants and technologists who are involved with the study conduct or patients; acts as a resource for hospital staff, patients and colleagues; directs research assistant and clerical staff; and supervises patient progress and follow-up.

**Working Conditions**:
In addition to areas of the hospital, out-patients visits are performed in clinical offices or remotely using approved virtual platforms (e.g. Zoom), and research recording and communication occurs within the research office. Attendance at clinical rounds and study meetings wi