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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

Acting as a Clinical Research Coordinator within the Division of Pediatric Hematology/Oncology/BMT, the individual will execute clinical protocols, support the Clinical Trials Unit (CTU) Manager and supervisor in clinical research protocol management and assist in the supervision of the Clinical Research Associates (CRA) group. The incumbent works collaboratively and closely with the CTU Manager, supervisor and the Research Services Manager.

The incumbent works with physicians and staff in the CRA office and Oncology clinic. Office is located in the Shaughnessy Building or BC Children’s Hospital Research Institute.

ORGANIZATIONAL STATUS

The incumbent will report directly to the Lead Clinical Research Coordinator (CRC), if applicable, and 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. 

WORK PERFORMED

Management – as applicable

• Manages and coordinates the daily operations of clinical trials as assigned by the CTU manager or Lead CRC.
• Supervises and trains staff (students, tech II and III) in clinical research protocol management and makes recommendations with respect to hiring.
• Develops training plans and timelines to align with GCP (Good Clinical Practice), evaluates ongoing training.
• Conducts performance evaluations and advises CTU manager on staff performance and work distribution.
• Develops and implements methodologies, policies, procedures and standards in clinical research protocol management.
• Advises CTU Manager or Lead CRC, on continuing quality improvement within work systems.
• Undertakes management projects and duties assigned by CTU manager

Study Conduct

• Reviews protocols and provides input on resource and feasibility.
• Interprets protocol details and organizes study activities.
• Oversees, coordinates and conducts complex clinical studies, trials, or registries, including but not limited to collecting data, administering questionnaires, collecting/shipping patient samples, and completion case report forms in accordance with GCP guidelines.
• Creates structure, processes, documents required for operation of new complex trials or registries
• Develops study-related documentation, novel procedures, data capture tools, and electronic databases to enhance data capture and meet study and program objectives.
• Responsible for accurate and timely completion and submission of data and internal monitoring.
• Responsible for audit and monitoring visits, including planning, participating in, addressing variances 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.

Collaboration

• Liaises with clinical staff in the conduct of study activities and adverse event reporting
• 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 or registries
• Corresponds with sponsors and external stakeholders on behalf of the PI as necessary
• Provides input for, coordinates, and/or chairs research committee meetings, external teleconferences, CRA meetings, and inter-departmental meetings, both patient and study focused.
• Attends related conferences and meetings.
• Demonstrates communication and general behavior which facilitates positive attitudes toward participation in clinic research.
• Performs other related duties as required.

CONSEQUENCE OF ERROR

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. Errors could impact upon the reputation of the program as a whole and jeopardize the options for collaborative participation with industry, government and other centers.

SUPERVISION RECEIVED

The incumbent will receive supervision and direction from the CRA Manager or Lead CRC 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.

SUPERVISION GIVEN

It is expected that the incumbent will demonstrate the ability to work independently and supervise the day to day activities of students, 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. Communicates effectively both orally and in writing. 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 will be supported to obtain within one year in this position.