Clinical Research Coordinator

Job Category

Job Profile

Job Title

Department

Compensation Range

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date

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

Job End Date

This position is expected to be filled by promotion/reassignment and is included here to inform you of its vacancy at the University

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 Centre for Cardiovascular Innovation (CCI) is a Faculty of Medicine approved research centre and is an inclusive centre with multidisciplinary membership for all cardiovascular investigators in BC. CCI has investigators affiliated with University of British Columbia, Vancouver Coastal Health Research Institute, Providence Research, BC Children's Hospital, Fraser Health and Island Health. The clinical research coordinator is responsible for planning, organizing, implementing, and coordinating clinical research trials at the Centre For Cardiovascular Innovation (CCI) in accordance with approved research protocols and ethics guidelines, and acting as a member of an interdisciplinary team conducting clinical research.

Organizational Status
The Clinical Research Coordinator will report to the Director, ARO Operations. The position will work closely with other staff to fulfill the operational requirements of the research centre.

Work Performed

- Responsible for planning, coordinating, implementing and evaluating the conduct of multi-center clinical trials

- Manages ethics communications, including submissions for initial approval, amendments, renewals and updates

-Coordinate regulatory submissions and compliance with local, national, and international laws, ensuring adherence to applicable regulations (e.g., the UBC Clinical Research Ethics Board, FIPPA, Health Canada, ICH GCP, Tri-Council Policy Statement, FDA, EMA).
- Acts as a key liaison with Principal Investigator (PI), sponsors and study sites.

-Develop and implement strategies to enhance patient recruitment, retention, and engagement at study sites

- Keeps Principal Investigators informed of any study related problems or trends in research data
- Identifies and troubleshoots problems, providing leadership and resolution.
- Designs and develops quality documentation on research subjects: source documents, Case Report Forms (CRF/eCRF's), resolving queries in a timely manner.
- Designs and develops data collection methodologies, instruments and databases
- Liaises with site clinical coordinators, research managers and Investigators for trial initiation,

maintenance and monitoring and ensuring enrolment expectations are met.

-Trains local and remote study teams in protocol adherence, data collection, database use, and other protocol-specific research activities.
- Conducts regular data reviews and site visits (remote or in-person) to monitor site performance, ensuring compliance with protocol, GCP guidelines, and regulatory requirements
- Generates progress and interim reports for presentation
- Prepares and follows up on initiatives or issues relating to research and clinical trials
- Provides leadership in the conduct of assigned clinical trials

-Advise and assist junior staff and trainees

-Negotiate budgets with clinical trial sites, and ensure activities are performed in accordance with agreed-upon budgets

-Developing and implementing study procedures and standard operating procedures (SOPs)

-Identify potential risks to study conduct and develop mitigation strategies to ensure timely resolution and maintain study quality.
- Ensures completion and confidentiality of the study including audits by sponsor and/or regulatory authorities
- Oversee patient safety, progress, and follow-up, ensuring timely documentation and resolution of any adverse events or protocol deviations

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.

In addition, study PIs will rely on the coordinator to alert them to clinical problems and unexpected events concerning study sites and trial conduct: 1) 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 and 2) Poor communication skills with sites could jeopardize their participation, and with sponsors and referring/community physicians would reflect badly on the reputation of the research centre

Supervision Received
Work closely with the Director, ARO Operations, the Clinical Director, and each study Principal Investigator (PI) as part of a collaborative team. This individual will be expected to work independently in accordance with established objectives; and exercise initiative and judgment in performing all work-related function

Supervision Given
Provide mentorship to new or inexperienced research staff

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of three years of related experience, or the 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

Preferred Qualifications

-Experience with clinical data collection, monitoring / auditing preferred.

-Knowledge of ICH/GCP guidelines preferred.

-Recognized certification in clinical research (ACRP or SOCRA) preferred.

-Project management skills preferred.

-Ability to manage project timelines and budgets.

-Ability to analyze a problem, conduct research, and come to an appropriate resolution.

-Ability to use sound judgment.

-Ability to manage conflicts.

-Ability to work independently and be self-directed.

-Ability to work well with others in a team environment.

-Ability to communicate clearly both verbally and in writing.

-Ability to work with a diverse group of people from varying backgrounds.

-Demonstrate ability to express complex technical concepts effectively.

-Mentor/training experience preferred.

-Knowledge of applicable legislative, UBC and/or departmental policies and procedures preferred.

-Client service oriented, with the ability to effectively work with diversity