Clinical Research Coordinator II Full-time

Clinical Research Coordinator II

Acting as the Clinical Research Coordinator II (CRC II), within the Division of Pediatric Hematology/Oncology/BMT, the individual will execute clinical protocols, support the Clinical Trials Unit (CTU) Manager in clinical research protocol management and train and educate staff. The incumbent works collaboratively and closely with the CTU Manager and Team Leads. The incumbent works with physicians and staff in the CRA office and Oncology clinic. Office is located in the Shaughnessy Building.

The incumbent will report directly to the CTU Manager. The incumbent will also report to and/or receive direction from the divisional Principal Investigators, Research Services Manager and the Director of Research.

Manages and coordinates the daily operations of clinical trials as assigned by the CTU manager or Team Lead.

Onboards, supervises and trains staff (students, tech II and III) in clinical research protocol management and makes recommendations with respect to performance.

Develops training plans and timelines to align with GCP (Good Clinical Practice), evaluates ongoing training.

Modifies and updates study-related documentation, procedures, data capture tools, and electronic databases to enhance data capture and meet study and program objectives.

Develops and implements projects, procedures and standards in clinical research protocol management and efficiency of the CTU, with support from the Team Lead and/or CTU Manager.

Providing Operational expertise and feedback on proposed study issues for feasibility review and when undergoing activation process.

Works closely with the Principal Investigators (PI) and Research Ethics Delegate (RED) regarding study activations.

Interprets protocol details and organizes study activities.

Creates structure, processes, documents required for operation start-up of new complex trials

Oversees, coordinates and conducts complex clinical studies and trials, including but not limited to data abstraction, administering questionnaires, collecting/shipping patient samples, and completion case report forms in accordance with GCP guidelines.

Responsible for external audit and monitoring visits, including planning, participating in, addressing variances, deviations and writing and implementing preventative action plans.

Demonstrates high level of independence and ownership on projects and duties. Able to troubleshoot issues independently and ask for PI input when necessary.

Supports clinical research by ensuring protocols will be conducted according to legal and ethical requirements.

Maintains accuracy, accessibility, and confidentiality of study records and reports.

Liaises with co-investigators, collaborators, the health care team and other research personnel both on-site and at national/international institutions for: project management, information exchange regarding assigned studies, and logistics to facilitate the operation of the studies.

Managing the archiving process for closed clinical research studies.

Attends related conferences and meetings as needed.

Demonstrates communication and general behavior which facilitates positive attitudes toward participation in clinic research.

Performs other related duties as required.

Exercises a considerable amount of judgment, responsibility, and initiative in determining work procedures and methods of the RT2 and RT3. The incumbent is required to conduct all research activities in an ethical manner, suited to the proper activities of the University of British Columbia and to the professional organizations governing his or herself and those governing the activities of the institution and all other investigators. Any procedures or data recorded as part of a trial must be accurate and must accurately reflect the work performed. Strict confidentiality of all study participants must be adhered to. All activities involving participants are accountable to the Principal Investigator, the Department Head, and the candidate's governing professional organization.

Consequences of error are high and this is a position with significant responsibility. The data submitted impacts the direction of future studies and audit findings may impact treatment options through clinical trials. Errors could impact patients receiving treatment on trial, the reputation of the program and jeopardize collaborative participation with industry, government and other centers.

The incumbent will receive supervision and direction from the CRA Manager within the Program. The incumbent works under minimum supervision, receiving specific instructions only on unusual problems or on matters which depart significantly from established policy and procedure.

It is expected that the incumbent will demonstrate the ability to work independently and supervise the day to day activities of student, tech II and tech III research staff.

Minimum Qualifications:

• Completion of a university degree in a relevant discipline or technical program and a minimum four years of related experience or an equivalent combination of education and experience. Some positions may require a graduate degree.
• 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:

• Knowledge of medical terminology and patient record systems required. Demonstrated knowledge and experience with Pediatric oncology an asset. Medium to high degree of computer literacy including familiarity with Microsoft Word, Access and Excel. Familiarity with database management programs an asset. Attentive to detail, with the ability to work quickly and accurately. Excellent organizational, interpersonal and communication skills a must. High degree of motivation, enthusiasm and initiative. Ability to effectively prioritize tasks and meet deadlines. Ability to exercise initiative and maintain confidentiality. Proficient in English language both written and verbal. Ability to learn new software. Ability to work both independently and within a team environment. Physical ability to do the job. SoCRA certification (CCRP) recommended or can be supported by the CTU.