Research Operations Manager

Job Summary

The Research Operation Manager of the Hematology Research Program (HRP) is responsible for the planning, management, coordination, facilitation, and communications of clinical research studies conducted within the HRP. Research Operation Manager works closely and collaboratively with investigators, sponsors, research institutes, granting agencies, hospital departments, clinical services managers, and other stakeholders. The Research Operation Manager oversees the overall coordination and execution of research projects and activities. To perform effectively, the Research Operation Manager must have an understanding of the research priorities of the HRP, the operations of the clinical services (including Leukemia BMT, Thrombosis, General Hematology and Apheresis) and relevant hospital departments (e.g. radiology, laboratory, pharmacy) in order to ensure that the allocation of research resources supports priorities and initiatives. Knowledge of regulatory requirements

and ethical guidelines on clinical trials is essential. HRP provides support and facilitates research activities of the Vancouver General Hospital Hematology and Leukemia Bone Marrow Transplant (BMT) Program. The studies conducted are broad based, ranging from registries to phase 4 clinical trials, pharmacokinetic and first‐in‐man studies, to health outcomes research qualitative studies. Research topics include hemostasis, thrombosis, transfusion, hematological malignancies, and stem cell transplantation and supportive care. There is close collative research with the Terry Fox Research

Institute, BC Cancer, and the National Cancer Institute. This position is located within a health‐care facility.

Organizational Status
The Research Operation Manager works independently and reports to the Research Program Manager and Director of HRP. The Research Operation Manager may supervise research coordinators, assistants and Co‐op students of the HRP. There is close interaction with students/residents, faculty, clinical service managers, administrative support staff, and internal and external collaborators. Effective liaison and partnership with hospital and university personnel relevant to research is mandatory.

Work Performed

• Ensures research projects activities are conducted in compliance with ICH‐GCP guidelines, institution SOPs, and research protocols.
• Liaises with investigators, sponsors, research ethic board and clinical programs, to ensure clear, effective and efficient communication.
• Communicates with research team members on study expectations, timeline and progress. Oversee
  research activities within HRP and maintain workload balance among team members.
• Discusses research project concerns and priorities with investigators and Research Program Manager,
  and provides recommendation to amend problems and ameliorate risks.
• Facilitates reviews of internal working procedures/practices and assists with working procedure
  implementation.
• Develops project plans and critical paths for successful completion of research projects and research
  deliverables.
• Facilitates divisional research meetings and meets with investigators, clinical program and research
  teams regularly to ensure efficient and effective conduct of studies.
• Reviews potential studies for operational feasibility and provides recommendation to investigators and
  Research Program Manager.
• Coordinates start‐up activities for studies, including but not limited to site visits, protocol‐specific
  training for research and clinical staff, timely completion of ethics submission, institutional approvals,
  regulatory documentation, and contractual agreements.
• Oversees a portfolio of studies concurrently from study start‐up to closure and ongoing study
  maintenance.
• Participates in study budget forecasting and preparation based on in‐depth review and understanding of study protocols. In discussion with Research Program Manager and acts on behalf of investigators,
  negotiates budgets and financial terms, with sponsors and vendors.
• Ensures all faculty and staff maintain updated training and act in compliance with regulatory and
  institutional requirements for human subjects research.
• Oversees internal quality assurance reviews and provides on‐going trainings to other research staff.
• Facilitates with hospital departments regarding protocol reviews, study training and workflow
  discussions.
• Additional duties as needed.

Consequence of Error/Judgement
This position works with a high degree of independence and has significant influence on the quality,
effectiveness and the sustainability of the HRP. Non‐compliance with contractual terms, sponsoring agency guidelines, Good Clinical Practice guidelines, regulatory (including Health Canada and FDA) requirements could result in the return of agency funds, loss of future funds and/ or inability to collect funds owned to the University, and potentially termination of research studies and activities. Incorrect interpretation of contracts, sponsoring agency and institutional policies, and inaccurate or untimely information provided to faculty could result in loss of funds and lead to financial hardship for HRP.

Supervision Received
Works independently in accordance with established objectives and strategic plans set forth by the Executive Committee of the HRP. Reports directly to Research Program Manager.

Supervision Given
Oversees incoming Research Coordinators, Research Assistants and Students; orientates and trains new 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

• Post‐graduate degree or equivalent professional designation with experience as research coordinator or project manager, or equivalent combination of education and experience in clinical trial research.
• Excellent interpersonal, organizational, and problem‐solving skills, including the ability to multi‐task a range of complex projects to meet required deadlines.
• Ability to work under pressure and handle frequent interruptions.
• Ability to work independently as well as in team situations.
• Demonstrated ability to think critically, analytically and respond to a broad range of situations with a high level of independence, sensitivity and confidentiality.
• Ability to exercise tact and discretion in dealing with external agencies, investigators and other stakeholders.