Research Operations Manager Clinical Trials Phase 1

2 weeks ago


Vancouver, Canada Providence Healthcare Full time

**Salary**: The salary range for this position is CAD $54.16/Hr. - CAD $77.86/Hr.
Summary:
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 in health-related field. Practicing Registered Nurse registration with British Columbia College of Nurses and Midwives Preferred.
- Seven (7) and 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 judgement in evaluating new initiatives and trials.
- Demonstrated written and verbal communication skills including the ability to create and deliver effective pre



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