Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator coordinates research and clinical trial initiatives focused on supporting Cardiac Sciences.

Organizational Status

Director of Research ->

Investigator and Attending Cardiologists ->

Research Manager ->

Research Coordinator ->

Research Assistants, Clerical Staff, Students

Work Performed

Develops and supervises implementation of clinical trials.

Develops and promotes activities relating to research and multi-centre clinical trials locally and internationally.

Designs and develops data collection methodologies, instruments and databases.

Oversees and coordinates data and specimen transfer.

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.

A key liaison with research manager, Principal Investigator (PI) and sponsors.

Provides leadership in all areas of research and clinical trials in the hospital and community.

Participates in developing and evaluating strategies to meet the clinical trial goals and objectives.

Reviews and implements research protocol.

Preparation of study documents including ethical submissions, regulatory documents and hospital research approvals.

Assists in clinical trial budgets.

Participates in identifying and applying for additional funding.

Facilitates participation of medical students and physicians in training.

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).

Manages study supplies, devices and drugs, is accountable to the Investigator, sponsor, federal regulatory bodies as per Good Clinical Practice guidelines.

Provides patient education as per study protocol.

Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.

Informs investigator, sponsor and UBC Clinical Research Ethics Board of any Serious Adverse Events to patients during the trial.

Obtains appropriate related study data including blood samples & ECG’s, hemodynamic measurements, and angiographic records.

Case management of ongoing follow-up assessment including history, physical exam, venipuncture, ECG, Doppler ultrasound and other diagnostic tests and counseling of outpatients.

Completes and corrects study records and case report forms independently or in consultation with the sponsor and / or their representative

Oversees completion and confidentiality of the study including audits by sponsor and / or regulatory authority.

Responsible for the overall conduct of the studies and as per Good Clinical Practice.

Ensures subject safety, regulatory compliance and enrollment expectations are met.

Meets deadlines for academic and industry sponsors.

Functions as a resource with hospital staff, patients and colleagues

Supervises nurses and technologists who are involved with the study conduct or patients.

Supervises patient progress and follow-up within study protocols and communicates to Investigator.

Attends sponsor Investigator meetings and study education sessions.

Attends education sessions related to clinical and regulatory updates, and professional development.

Attends off hours on-call duty and availability to come to the hospital.

Consequence of Error / Judgement

The Coordinator is responsible for :

a) Clinical mistakes made by Coordinator could be life threatening to patients. Ensuring patient safety includes :

• accurately judging study eligibility
• updating clinical skills and knowledge to meet the demands of clinical complexity

b) 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.

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, Good Clinical Practice
• provincial : B.C. Privacy Act
• federal : Health Canada, International Conference on Harmonization, Tri Council Policy Statement
• international : U.S. Federal Code of Regulations (FDA), Declaration of Helsinki

In addition, the Manager and Director rely on the Coordinator to alert them to clinical problems and unexpected events concerning study patients and trial conduct.

c) Lack of study enrollment and completion of work according to deadlines would threaten loss of funding and consideration for future invitations to participate in clinical trials.

Supervision Received

The Clinical Research Coordinator reports to the Research Manager, Principal Investigator, attending Cardiologists, and the Director.

Since the conduct of a trial may involve working independently, the coordinator is responsible to apprise the Manager and Director of any important communication or events.

Supervision Given

The Coordinator acts as a resource with hospital staff, patents and colleagues; directs research assistant and clerical staff;

and follows patient progress and discharge. Delegated tasks include, organizing study documents.

Minimum Qualifications

Registered Nurse with BCCNP plus a minimum of one year of nursing 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

Preferred Qualifications

Strong computer skills including Word, Excel and electronic communications.

Effective oral and written communication, supervisory, problem solving, interpersonal, multi-tasking and excellent organization.

Demonstrates responsibility and accountability.

Cardiac research experience is an asset.

Is self-directed and has the ability to exercise judgment and initiative, team-oriented, committed and precise.

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.

Performs as a critical thinker and has the ability to operationalize a protocol into a functional study.

Demonstrates ability to work effectively and precisely under pressure and time constraint (accuracy and attention to detail required).