Clinical Research Manager

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Job Profile

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Department

Compensation Range

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Posting End Date

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

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
The Clinical Research Manager (CRM) is responsible for managing research activities of the Respiratory Medicine Division at the Centre for Heart Lung Innovation (HLI) located at St. Pauls Hospital in downtown Vancouver. The CRMs will be responsible for the regulatory and operational provisions and administration of two multi-site research projects and will manage several research coordinators assistants and students executing the research activities in accordance with study protocols within an allocated budget and timelines. The CRM will liaise with internal and external clinical and administrative staff to ensure the successful achievement of study goals and milestones while maintaining high security privacy and ethical practices.

Organizational Status

The CRM will report directly to the Clinical Research Services Core Manager and receive supervision from the Principal Investigator(s). The CRM will work collaboratively with professional staff (nurses physicians technicians) and directly supervise research coordinators assistants and students.

The UBC Centre for Heart Lung Innovation at St. Pauls Hospital brings together basic and clinical scientists in an exciting multidisciplinary environment to address heart lung and critical care disease. The HLI is the largest translational research centre within Providence Health Cares St. Pauls Hospital comprised of 50 Principal Investigators (PIs) of whom approximately 40% conduct clinical research and over 300 Scientists and staff. Education is provided to over 130 undergraduate graduate and postgraduate students.

Work Performed

• Facilitate the transition of a large-scale national clinical registry (CARE-PF) into an electronic data capture system create new Standard Operating Procedures (SOPs) and manage access to the data.
• Lead patient engagement in governing the above-mentioned registry transition and management.
• Establish a coordinating site for a multi-site national study (CAN-Impact) and manage research activities and administration.
• Manage finances and budgets of the projects including invoice preparation payment tracking budget forecasts financial reports and other required financial documents. Coordinate with the finance team to resolve any financial issues that may arise and report routinely to PIs on financial status of the projects.
• Prepare ethics and regulatory applications amendments and renewals and draft annual reports.
• Develop and regularly update organizational and study-specific Standard Operating Procedures (SOPs) to ensure compliance with ICH/GCP guidelines and clinical operations.
• Lead local and national study team meetings. Establish effective communication with all team members.
• Develop work priorities for the research project team manage workload establish timelines and ensure research objectives and deadlines are met.
• Liaise with physicians and other hospital staff to establish and coordinate study operations within hospital departments including laboratories radiology IT and outpatient services.
• Develop and oversee patient enrollment strategies.
• Review study progress with the study team and initiate necessary actions to improve progress if needed.
• Maintain the accuracy accessibility and confidentiality of study records and reports. Manage and implement quality assurance strategies. Maintain accurate and timely data collection and handling of subject records by research staff including audit processes education and training of study personnel and trainees.
• Execute queries and conduct preliminary data analysis on study database(s).
• Contribute to the development of investigator-led and study protocols.
• Assist the Core Manager in hiring training and supervising new research staff.
• Contribute to academic publications and present at academic conferences.
• Perform other duties as needed.

Consequence of Error/Judgement

This position exercises professional judgement and initiative in managing various research activities with a high level of independence. Failure to act professionally and tactfully would harm patients and various UBC and healthcare departments. Poor judgment or errors and failure to follow protocols guidelines and policies could seriously compromise the quality of the research and result in delays in completing projects.

Inability to complete work at a high level of accuracy and efficiency may adversely affect the quality and significance of the research and the reputation of the PIs. Activities such as database documentation of maintenance and access research and support for both internal and external researchers are all critically dependent on the security and privacy of information systems that have been developed and are maintained. Any breach in confidentiality or data security would place the future of the research projects at risk. Inadequate documentation organization communication and planning may adversely affect the credibility and ability to secure future funding of investigators staff and trainees.

Supervision Received
The CRM works independently and reports directly to the Clinical Research Services Core Manager. The CRM receives supervision from the Principal Investigator(s) and collaborates with professional staff (nurses physicians technicians).

Supervision Given
The CRM will supervise research coordinators assistants and students.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience or an equivalent combination of education and experience.

- Willingness to respect diverse perspectives including perspectives in conflict with ones own

- Demonstrates a commitment to enhancing ones own awareness knowledge and skills related to equity diversity and inclusion

Preferred Qualifications

• At least two years of experience in managing health research projects.
• Experience in managing multi-site clinical research in a hospital academic setting research environment healthcare organization or related industry is preferred.
• Sound knowledge of quantitative research methods implementation and outcome assessment applicable to health and/or partnered research.
• Experience with large-scale digital clinical data systems is an asset.
• Experience with Patient and Public Involvement and Engagement in research approaches is an asset.
• Demonstrated data analytics and statistical interpretation skills.
• Sound knowledge of medical clinical and research terminology.
• Excellent computer skills (MS Office). Working experience with Redcap an asset.
• Demonstrated ability to think critically and respond in a broad range of activities with high independence.
• Exceptional organizational skills and demonstrated ability to maintain high accuracy and attention to detail efficiently.
• Excellent interpersonal skills and the ability to act tactfully and respectfully with people from diverse personality types and socioeconomic backgrounds.
• Demonstrated effective oral and written communication skills.
• Ability to exercise sound judgment work under pressure prioritize workload and meet deadlines.
• High intrinsic motivation and the ability to be self-directed and work independently and within a team environment.
• Demonstrated initiative and the willingness to work closely with team members to resolve problems quickly and appropriately.
• Willingness to respect diverse perspectives including perspectives in conflict with ones own
• Demonstrates a commitment to enhancing ones awareness knowledge and skills related to equity diversity and inclusion.
• Able to occasionally work flexible hours (mornings/evenings) due to research activities schedule such as sample collection procedures or focus groups.
• Current certification in GCP Health Canada Division 5-Drugs for Clinical Trials Involving Human Subjects TCPS-2 an asset.