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

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At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Job Summary
The Research Coordinator will help to create and lead a pan-Canadian Cardio-Obstetrics network through which a number of retrospective and prospective studies will be undertaken over the next 5 years.

Organizational Status

The Research Coordinator reports to the Research Manager, the Investigators and Attending Cardiologists and the Director of Research. The Research Coordinator will be supervising the Research Assistants, Clerical Staff and Students

Work Performed

• Assists in the planning, organizing and delivery of 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.
• Participates in developing and evaluating strategies to meet the clinical trial goals and objectives, overseeing project progress and ensuring enrolment expectations are met.
• 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.
• Coordinates research subject treatment/tests with various departments, physicians and other study staff personnel.
• 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 consult PI accordingly
• Resolves any data related queries.
• Identifies, writes, and submits applications 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.
• May train and supervise students as needed in accordance with study requirements and project goals.
• Organizes and leads the Network and any related meetings
• Assists in writing manuscripts
• Oversees contracts with other sites across Canada
• Assists coordinators at other sites across Canada
• Implements recruitment strategies; coordinates and conducts patient recruitment in clinic
• Maintains patient confidentiality.

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

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

Preferred Qualifications

Education/ Work Experience

Completion of a Bachelor’s of Science and a minimum three years of related experience or an equivalent combination of education and experience. Previous experience in clinical drug trials, ethics board submissions, data entry, computer skills, medical terminology. 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.

Skills

The Clinical Research Coordinator is expected to work collaboratively as part of a team with other research staff, hospital staff, attending physicians, support staff, grant and industry sponsors and their representatives, regulatory agents and clinical investigators.

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