Job Description

Staff - Non Union

Job Category M&P - AAPS

Job Profile AAPS Salaried - Research and Facilitation, Level B

Job Title MS MRI Research Manager

Department MS MRI and MS NMO Research Division of Neurology | Department of Medicine | Faculty of Medicine

Compensation Range $5,468.83 - $7,878.17 CAD Monthly

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date July 20, 2023

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

Job End Date Aug 1, 2024

This position is located within a health-care facility, therefore, the successful candidate will be required to provide verification of full vaccination against Covid-19 provided prior to the start date, as required by a provincial health mandate.

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
Working closely with the Principal Investigator(s) of the MS MRI Research Group, this position is responsible for managing all activities related to local, national, and international clinical research projects within MS MRI and responds as required to the informational needs of potential collaborative centres, investigators and sponsors. The Manager of MS MRI is also responsible for providing consultative services in data analysis, assessing operational needs, making recommendations, developing detailed plans and reports that support the research goals of MS MRI.

Organizational Status

Works within the MS & NMO Research Program under guidance of the MS MRI Principal Investigators (PI\xe2\x80\x99s). This individual will work independently to support local, national and international sites to ensure quality scans received by MS MRI for analysis. S/he will manage a team of database developers, research coordinator, research assistant, and students in all day-to-day aspects of their job to ensure that projects meet expected timelines and deliverables. This position liaises with external Principal Investigator(s), research ethics committees, University Industry Liaison Office, pharmaceutical companies and funding agencies, and various members of internal and external Key Opinion Leaders and Small and Medium-sized Enterprises.

This position must work independently, within standard and acceptable boundaries for ethical and competent research practice. The incumbent will be accountable to the PI(s), as well as within the guidelines of MS & NMO Program standard processes, UBC Research Ethics Board, international research regulations (ICH-GCP), Health Canada Div. 5 Part C, provincial and federal (FIPPA & PIPEDA) privacy regulations and UBC staff practices.

Work Performed

Operational management:

• Oversees operational needs and approves purchasing of computer hardware, software, lab furnishings, servers, Educloud etc. for the team.
• Together with the database developer/analyst, work with UBC IT on the continual improvement of the MS MRI computing infrastructure.
• Organize program-wide collaborative meetings to discuss MRI-research activities, review upcoming MS Clinical Trials and propose local research projects.
• Participate in lab operation and safety committees, implement safety protocol within the lab, and ensure team members adhere to latest safety regulation
• Manages user access and security to MS MRI VPN, team share, and MS MRI network account for authorized personnel

Team management:

• Provides direction, technical knowledge, and functional direction to the team
• Responsible for hiring of research staffs and students
• Supervise and train research staffs in activities related to the receipt, processing, quality control, and archiving of MRI data to ensure consistency.

• Ensure the research team follows standard operating procedures

Study management:

• Manage research projects and lead appropriate work plans and timelines, ensuring project milestones and deadlines are met
• Collaborate with MS MRI PIs in setting research project priorities and goals
• Support project proposals/grants application
• Facilitate the research review process and developing collaborative agreements with internal and external legal teams, researchers, granting agencies, and departments in VP research
• Liaise with pharmaceutical companies and CROs for project proposal initiation, maintenance, monitoring, and closure.
• Oversees preparation and submission of documentation to regulatory bodies, such as Health Canada, and UBC ethics committees for approval
• Develop and implement study-related documents (eg. standard operating procedures for privacy and data governance, MRI Procedure Manuals, policies) for investigators, sponsors, and collaborating sites
• Consult with MRI Technologist to customize MRI Protocols and MRI Scanning Parameters for investigator-initiated studies and clinical trials.
• Train site-coordinators on MRI data anonymization and data transfer.
• Consult with radiologists regarding MRI-related or data compliance issues
• Work with participating MRI sites to review MRIs quality and qualify their participation in clinical trials.
• Report MRI-related logistical challenges, protocol violation, and provide solutions at Investigator meetings, MRI workshops, study-specific meetings, and/or via email
• Prepares weekly status report, progress (annual, quarterly) and/or final report for sponsor or external Principal Investigator(s)
• Participate in the writing and reviewing abstracts, posters, and manuscripts for local, national and international presentation/publication
• Attend Investigator meetings, teleconferences and education/workshop sessions.
• Work closely with the Finance Coordinator for budget development and management

Quality and regulatory management:

• Conduct internal research audits to ensure compliance with Standard Operating Procedures (SOPs) and make revisions as needed.
• Prepare the necessary documents for site inspection, support onsite inspections, and draft post-inspection response.
• Ensure that all study-related activities adhere to UBC Clinical Research Ethics Board, ICH-GCP guidelines, TCPS2, Health Canada, B.C. Freedom of Information and Protection of Privacy Act, PIPEDA, and/or U.S. FDA

Other tasks:

• Attend relevant program related meetings and represent MS MRI at planning meetings and events.
• Travel as required to attend meetings and conferences (local, national, international).
• Perform other duties as required to meet contract deliverables and timelines.

Consequence of Error/Judgement

Lack of careful attention to regulatory guidelines and approval could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. The performance of clinical trials and research projects must strictly conform to appropriate regulations:

- Personal: maintaining professional behavior and respect for staff

- Local: the UBC Clinical Research Ethics Board

- Provincial: B.C. Privacy Act

- Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and

International: U.S. Food & Drug Administration

Lack of careful attention in the image QC, results QC, and reporting of results could lead to invalid data being shipped to the sponsor or collaborator, resulting in a loss of reputation of the investigators and university, and potential loss of funding and/or legal action from the sponsor for breach of contract

Supervision Received
Training and supervision for this role will be provided by the PI(s)of MS MRI. Additional training and support will be provided by Radiologists, and/or other members of the team. Reports directly to the PI(s) who will also provide broad directives.

Supervision Given
The Manager advises/and oversees research staff and students. The Manager acts as a resource for the MS & NMO Program researchers on matters of Good Clinical Practice and Quality Assurance compliance, and can bring specialized expertise relevant to image analysis for large multi-centre studies.

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\xe2\x80\x99s own

- Demonstrates a commitment to enhancing one\xe2\x80\x99s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

Graduate (Masters or PhD) degree in a relevant discipline is preferred. Experience in quality assurance focused clinical research. Knowledge of Health Canada, FDA and ICH-GCP requirements. Experience in a supervisory role an asset. Working knowledge of research methodology and design. Strong familiarity with basic office software (e.g., MS Word and Excel) is required. Knowledge of image processing methods, particularly in medical imaging, is a strong asset.

Project management, analytical and organizational skills; excellent teaching, training, facilitation and presentation skills and experience. Possession of a strong work ethic with excellent interpersonal and time management skills, demonstrate the ability to communicate effectively both verbally and in writing, customer service skills are required. The incumbent is expected to perform to an exceptionally high level of professional work standards. Extensive experience in needs assessment and requirements analysis, technical and process improvement solutions analysis and design, and liaising with internal and external stakeholders. A highly motivated and self-starting person, the successful candidate will be expected to proactively solve problems creatively in a challenging environment with limited supervision and direction. The ability to effectively manage changing and competing priorities is essential. In addition, the successful applicant must thrive in a team setting in a diverse, complex, distributed and fluid environment.

University of British Columbia