Research Operations Manager, Clinical Trials Phase 1 Unit (PHC Research)
- PHC Multi-Site: Mt St Joseph Hospital
- LMC Multi-Site:
- Categories: Management/Non Union
- Min Hourly: 54.16 CAD
- Max Hourly: 77.86 CAD
- Salary grade: 09F
- Employment type: Regular Full-Time
- Rotation: Days
- FTE: 1.00
- Schedule:
- Union: 970
- Labour agreement: EXCL
Role Snapshot
- Req ID: 52971
- Location: Vancouver
- Work Site: Mt St Joseph Hospital
- Primary site: Mt St Joseph Hospital - 3080 Prince Edward Street Vancouver, British Columbia V5T3N4 Canada
What You Will Do
Providence Research is now hiring for a Research Operations Manager to be a leader in the management of research activities within a new Phase 1 Unit at Mount St. Joseph's Hospital in beautiful Mount Pleasant.
Reporting to the Providence Research (PR) Director, Clinical Research Administration and working in collaboration with the Physician Lead, the Research Operations Manager, Phase 1 (P1) Unit, provides leadership and strategic direction for the overall management of research activities within the P1 Unit including operational support, day-to-day supervision of staff, and financial management.
The Research Operations Manager fosters effective working relationships between the P1 Unit, Mount Saint Joseph (MSJ) clinical personnel, relevant Providence Health Care (PHC) departments/programs, PR, and university departments. Serves as a liaison between external stakeholders, including sponsors, industry partners, investigators, and academia, and the P1 Unit and works closely with the Physician Lead to oversee and enhance the operations of the P1 Unit, ensuring seamless integration into the hospital services setting.
In addition, in partnership with the PR Director, Clinical Research Administration, Physician Lead and Regulatory Lead, the Research Operations Manager reviews potential clinical trial projects for feasibility, ensuring the efficient utilization of the P1 Unit to drive overall sustainability and quality performance. Conducts high-level reviews of new potential ethical and contractual considerations. The Research Operations Manager also oversees and manages systems and processes that support contract tendering, negotiation, approval, and implementation.
Your duties will include:
- Operational Leadership: Manages the strategic planning, operations, and oversight of all clinical trials within the Phase 1 Unit, ensuring protocol adherence, resource allocation, and the efficient, high-quality conduct of trials.
- Stakeholder Collaboration: Works closely with the Physician Lead, sponsors, and regulatory bodies to ensure trial feasibility, coordinate ethical reviews, and maintain compliance with Health Canada and international clinical research standards.
- Team Supervision and Development: Leads and supports the unit's staff, handling recruitment, training, task allocation, and performance evaluations, while fostering a collaborative and productive work environment.
- Financial and Quality Management: Manages the unit’s budget, including trial-related expenses, and oversees billing and financial reporting. Ensures quality assurance through adherence to regulatory and ethical guidelines and prepares for audits and inspections as required.
What You Bring
Education, Training and Experience
- Bachelor’s degree in a health-related field. Practicing Registered Nurse registration with British Columbia College of Nurses and Midwives Preferred.
- Seven (7) to ten (10) years of experience working in both pharmaceutical, biotechnology industry and grant-funded academic clinical trials, including experience in an administrative/management position within a health care environment.
- Two (2) years of clinical research site management experience including supervision of research staff.
- Completed Good Clinical Practice (GCP) /Tri-council Policy (TCPS 2.0)/TDG/Health Canada Div 5 certifications, commitment to re-certifying every 2 years.
- Certification and ongoing membership in either SOCRA or ACRP.
- Proficient in Microsoft 365 and Adobe Acrobat.
Preferred:
- Experience with regulatory agency inspections at the site level.
- Experience with various trial Electronic Data Capture systems.
- Familiar with CERNER or equivalent electronic medical records system.
- Experience writing and implementing Corrective and Preventive Action Plans.
Knowledge, Skills, and Abilities
- Demonstrated experience in analyzing and improving operations and procedures, formulating, and implementing new policies and developing new strategies and procedures.
- Demonstrated experience with Research Ethics Boards and knowledge of Provincial and Federal regulatory requirements.
- Demonstrated experience with reviewing clinical trial protocols and operationalizing these at the site level.
- Demonstrated ability to understand complex documents (e.g. protocols, product monographs, investigator brochures, SOPs, technical manuals).
- Relationship management to promote collegiality within teams, staff, executives, collaborators, partners and funders, and proven experience in identifying opportunities to build new or expand existing relationships. Conflict resolution skill is an asset.
- Strategic and project management, planning and execution skills. Ability to use judgment in evaluating new initiatives and trials.
- Demonstrated written and verbal communication skills including the ability to create and deliver effective presentations.
- Demonstrated creativity and originality in problem identification and resolution and ability to communicate with and facilitate dialogue between diverse groups.
- Exceptional organizational and multitasking skill, with a keen attention to detail.
- Ability to thrive in a fast-paced and dynamic environment, managing competing priorities and meeting deadlines.
- Proven experience in all aspects of research budget development, management, and reporting. Demonstrated experience in scope, time, cost, and quality management.
- Demonstrated experience in effective leadership skills and ability to provide motivational leadership to staff.
What We Offer
- Competitive salary: $106,026 - $152,413 CAD per year, depending on experience.
- Comprehensive benefits: Eligible employees receive a robust medical and dental benefits package, including 4 weeks paid vacation starting.
- Pension plan: Work towards a comfortable retirement through employer-matched contributions to one of Canada's strongest pension plans!
- Meaningful impact: Your dedication and expertise will directly impact the lives of patients, including many from marginalized communities, helping contribute to the public healthcare system we're privileged to have here in BC.
- Growth opportunities: We welcome individuals at all stages of their career, offering opportunities for professional development and growth.
- State-of-the-art facilities: The new St. Paul’s Hospital and health campus will be the most innovative approach to the delivery of integrated care in B.C. and Canada, designed to appropriately address the future health needs of patients, families and our communities. From hospital care to primary and community health solutions, the new St. Paul’s Hospital and health campus will continue to lead innovations in care, research, and teaching. The new St. Paul’s Hospital is expected to open in 2027.
- Inclusive culture: We respect the diversity, dignity and interdependence of all persons. We value the cultural richness that our diverse workforce brings to the care of our equally diverse population of patients and residents.
Who we are:
Providence is a non-profit healthcare provider with over fifteen sites, including a large tertiary hospital in the heart of Vancouver’s beautiful and vibrant Downtown, a smaller community hospital in the idyllic Mount Pleasant neighborhood, one of the largest referral centres for rehabilitation in British Columbia, and five long-term care facilities, as well as other clinics.
As a leading teaching and research organization, and the provincial referral center for Cardiac, HIV/AIDS, and Renal Care, we provide services ranging from acute and long-term care to leading substance use and addiction treatment supporting some of BC’s most marginalized communities. Guided by the motto “how you want to be treated,” delivering exceptional patient and family-centered care is our mission.
Your Day to Day:
- Provides leadership in developing, planning, implementation of the strategic direction, and operations of the P1 Unit including oversight of all trials and investigational work conducted in the P1 Unit.
- Collaborates with Physician Lead, Regulatory Lead, and sponsors to ensure the trial design and requirements are feasible and implementable within the unit, and develops strategies, initiatives, programs, and deliverables for trials.
- Develops and maintains policies, processes, tools, training programs, and standard operating procedures relating to service activities for the P1 Unit consistent with applicable PHC nursing and other relevant policies, procedures, and guidelines with the objective of providing a high quality, value-added service while running a smooth and efficient operation.
- Coordinates and integrates the clinical research administration process to meet the needs of researchers/investigators ensuring optimal utilization of resources, including resource determination, allocation, and training. Understands available resources for the program/unit and keeps quality in the forefront of all resource utilization decisions keeping in mind the growth of existing and new services.
- Supervises all trials, including staff working on the trials being conducted at the P1 Unit from start to close out.
- Ensures clinical trial protocols are followed and carries out trial assessments when required to assist smooth conduct of trials in the P1 Unit. Consults with sponsor/clinical research associates and facilitates communication with personnel and participants to maintain efficient workflow.
- Prepares or reviews trial-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, research ethics board documents, and progress reports.
- Manages the procurement process for unit supplies.
- Provides supervision and guidance to unit staff, which includes task allocation, identifying new staffing needs, conducting orientation, and training, and troubleshooting staff challenges and needs. Establishes clear definitions of responsibility for each employee; reviews workload assignments and adjusts to meet operational needs; and motivates employees to achieve peak productivity and performance. Fosters team spirit, trust, and mutual respect.
- Recruits, selects, and hires staff in collaboration with appropriate Providence Research and PHC human resources (HR) staff.
- Monitors and supports staff performance including conducting timely performance reviews. Consults with HR Partners on performance matters and initiates discipline, as required, up to and including termination. Works with HR on matters such as grievance management and essential services planning if required.
- Receives and processes requests for applications for new trial intake.
- Ensures that P1 Unit trials are compliant with internal and external policies and procedures under which clinical trial agreements and Service Agreements are established.
- Ensures that all trials undertaken in the P1 Unit comply with the ethical guidelines outlined in the Tri-Council Policy Statement (TCPS2), legal requirements of Health Canada’s Food and Drug Act, Division 5, and international standards outlined in ICH E6 R2 Good Clinical Practice (GCP).
- Provides guidance for PHC trial operational approvals and ethics applications, including preparation of PHC REB ethics applications (where applicable).
- Oversees and communicates policies, processes, and procedures to ensure effective data capture, data integrity, and data security for trials with the P1 Unit.
- Manages the operating budget of the unit, including trials in a manner that is financially responsible and consistent with the overall goals of the organization. Develops and implements annual P1 Unit budget, forecast and financial reporting in conjunction with PHC/Providence Research Finance.
- Monitors operating account and authorizes expenditures. Provides feedback and detailed analysis on budget variances and works with PHC Finance to make recommendations for corrective action.
- Formulates fees for services and processes related to the conduct of trials. Oversees invoicing for services and payment collection.
- In collaboration with the Regulatory Lead, reviews the development and compliance of quality assurance and improvement programs for the Unit consistent with regulatory requirements. Prepares for and participates in quality assurance audits or inspections conducted by study sponsors and Health Canada.
- Advises and provides guidance/recommendations to operations administrators, clinically-appointed faculty, PHC partners supporting the unit regarding policies and clinical trial agreement terms, PHC policies and procedures.
- Develops strategic partnerships to increase business and collaboration with external research centres. Maintains relationships with key stakeholders, as advised by Providence Research, regulatory authorities, and other agencies.
- Builds collaborative relationships, and communicates directly with sponsors personnel, Providence Research staff, pharmaceutical/biotechnology partners, clinically appointed faculty, PHC REB and private research ethics boards (as applicable), biosafety, infection control, legal, privacy and other relevant administrative personnel at PHC and UBC. Participates on committees and working groups as required both internal and external to the organization.
- Ensures regulatory compliant records management throughout the trial’s life cycle including archiving requirements.
- Works with Providence Research and PHC Communications teams to promote public relations and communication activities (i.e. Research Awareness) and promotes the work of staff by targeting opportunities for knowledge exchanges with other stakeholders.
- Performs other related duties as required.
We acknowledge that Providence Health Care and the new St. Paul’s Hospital site is located on the traditional, ancestral, and unceded territory of the Coast Salish Peoples, including the territories of the xʷməθkwəy̓əm (Musqueam), Skwxwú7mesh (Squamish), and Səl̓ílwətaʔ/Selilwitulh (Tsleil-Waututh) Nations.
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