Clinical SCI Project Manager

University of British Columbia - Vancouver, BC (30+ days ago)

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Job Posting

Job ID:
38571

Location:
Vancouver - Hospital Site

Employment Group:
Management&Professional (AAPS)

Job Category:
Research & Facilitation

Classification Title:
Research&Facilitation, Level B

Business Title:
Clinical SCI Project Manager

VP/Faculty:
Faculty of Medicine

Department:
ICORD

Salary Range:
$64,339.00 (minimum) - $77,237.00 (midpoint) - $92,684.00 (maximum)

Full/Part Time:
Full-Time

Desired Start Date:
2020/11/16

Job End Date:
Possibility of Extension:
Yes

2021/11/15

Funding Type:
Grant Funded

Closing Date:
2020/10/30

Available Openings:
1

Guiding principle: "Midpoint" of the hiring salary range means the individual possesses full job knowledge, qualifications and experience.

Job Summary

Plans, coordinates, manages and expedites clinical SCI research activities within the Kwon Lab, in close coordination with the Vancouver Spine Research Program (VSRP). Facilitates the initiatives that comprise the clinical end of the translational research spectrum within the Kwon Lab research program.
Oversees current and upcoming clinical research studies, including the "Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study (CASPER)," ClinicalTrials.gov Identifier: NCT03911492.

Organizational Status

ICORD is a world leading health research centre focused on spinal cord injury. From the lab-based cellular level of understanding injury to rehabilitation and recovery, our researchers are dedicated to the development and translation of more effective strategies to promote prevention, functional recovery, and improved quality of life after spinal cord injury. Located at Vancouver General Hospital in the Blusson Spinal Cord Centre, ICORD is supported by UBC Faculties of Medicine and Science, and Vancouver Coastal Health Research Institute. Visit www.icord.org.
The Vancouver Spine Research Program provides the research infrastructure for the Vancouver Spine Surgery Institute (VSSI). Research is an integral part of the VSSI with much of the work directed towards improving the health and quality of life of spine patients in the areas of traumatic spine injuries, spine oncology, spine deformity and other spine conditions. The research team works with investigators and staff within the Acute Spine Unit and other Vancouver Coastal Health and UBC departments, in addition to investigators within ICORD and other research groups, both nationally and internationally.

The Kwon Lab at ICORD is a translational research program devoted to SCI and conducts the basic scientific research studies related to SCI. The VSRP provides the clinical research infrastructure for the Vancouver Spine Surgery Institute (VSRP).

The Clinical Research Manager is based in the Kwon Lab at ICORD and also an integral part of the Vancouver Spine Research Program, serving as the conduit between the clinical and basic elements of SCI research. Reports to Dr. Brian Kwon, PI of the Kwon Lab and Director of the VSRP, and works very closely with other staff and trainees in the Kwon Lab and VSRP. Regularly interacts with staff at UBC central agencies such as ORS, CREB, UILO, Financial Services. Liaises with personnel at external REBs, granting agencies, sponsors, other hospitals, and other research sites participating in multi-centre trials as required.

Work Performed

Plans and manages clinical research studies, including: working directly with investigators to develop study protocols, creating study documents such as informed consent forms, case report forms and SOPs, preparing and submitting UBC REB applications, preparing and obtaining departmental approvals for hospital operational applications, drafting research project budgets, and completing other required institutional research documentation.

Expedites research projects by critically reviewing study documents from sponsors/clinical research organizations, investigators, and other internal or external researchers. This involves creating a project-specific review document that outlines questions and recommendations, providing operational expertise and advice to researchers. This essential procedure allows the Kwon Lab and the VSRP to be both efficient and productive, ensuring clarity and expeditious review of new projects. This streamlined approach is particularly important in the initial phase of studies to determine feasibility and to provide guidance in operationalizing projects.

Acts as the central coordinator for multi-centre trials lead by Dr. Kwon, providing ongoing support to all sites, including: evaluating sites for feasibility of conducting trials; organizing site initiation visits; coordinating and providing site training; liaising with sites for approval of research agreements; organizing study supplies for each site; ensuring ongoing compliance with study protocol and organizing regulatory requirements; and regularly communicating with all participating sites.

Manages clinical and scientific data for multiple projects utilizing spreadsheets and databases on different platforms such as Microsoft Excel, Microsoft Access-based programs and proprietary web-based applications. Coordinates the ongoing review of research data, distribute data quality queries and monitor resolution of queries by study sites.

Reviews site-reported SAEs (serious adverse events) with the data safety team, which includes the medical monitor and the PI. This may involve communicating with sites to clarify details of SAEs and obtaining information on the status and resolution of SAEs. As required, the Clinical SCI Project Manager will coordinate reporting of SAEs to regulatory authorities, sponsors or institutional review boards.

Organizes study site payments by reviewing approved budgets, confirming study procedures completed by sites, and overseeing the preparation and submission of invoices for processing by finance departments.

Provides regular status updates on research projects to VSRP and Kwon Lab colleagues. Contributes to quarterly reporting of grants and other requirements, as needed,

Performs other related duties from time to time, as required.

Supervision Received

The Clinical SCI Project Manager reports to Dr. Kwon.

Supervision Given

The Clinical SCI Project Manager may supervise some research staff, including research assistants and volunteers, providing guidance and delegating specific responsibilities.

Consequence of Error/Judgement

The Clinical SCI Project Manager exercises professional judgment and initiative in the conduct of, and in managing clinical research studies. Working closely with the PI (Dr. Kwon) and with the VSRP and Kwon Lab teams, the Clinical SCI Project Manager ensures that study procedures are performed consistent with the study protocol, applicable hospital procedures, ethical guidelines and regulatory policies.

Establishing effective working relationships within the team, with other UBC and VCH departments and other stakeholders is essential in the success of the research programs. Inability to establish and foster effective working relationships may affect the integrity of the Kwon Lab and the VSRP, and the successful and timely completion of research projects.

Inappropriate disclosure of research participants' personal information would contravene privacy legislation and could result in legal action. Errors in data, reference materials or publications if detected, would result in delays, requiring additional resources to obtain or validate data.

Qualifications

Undergraduate degree in a relevant discipline. Minimum of three years' experience or the equivalent combination of education and experience. Advanced degrees (MSc or PhD) an asset. Minimum of three years experience or the equivalent combination of education and experience. Minimum of three years' experience in managing and conducting industry-sponsored clinical trials and investigator-initiated clinical research studies. Previous experience as study coordinator within a hospital setting an asset.

Skills required:
  • Ability to communicate effectively verbally and in writing.
  • Excellent interpersonal and organizational skills.
  • Ability to work effectively independently and in a team environment.
  • Ability to apply sound analytical skills, exercise initiative, good judgement, poise and discretion while working in an acute clinical environment and with sensitive medical information.
  • Ability to listen actively and attentively, and obtain clarification as required.
  • Ability to analyze problems, identify key information and issues, and effectively resolve.
  • Ability to efficiently and effectively coordinate tasks.
  • Ability to make thoughtful, informed, and thorough decisions.
  • Ability to develop and maintain cooperative and productive working relationships.
  • Ability to deal effectively with a diversity of people in a calm, courteous and effective manner.
  • Ability to conduct research interviews to obtain accurate, complete, and relevant information.
  • High degree of proficiency in computer applications such as Microsoft Word, Excel, Powerpoint and Access; and relevant web-based applications and tools.
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Equity and diversity are essential to academic excellence. An open and diverse community fosters the inclusion of voices that have been underrepresented or discouraged. We encourage applications from members of groups that have been marginalized on any grounds enumerated under the B.C. Human Rights Code, including sex, sexual orientation, gender identity or expression, racialization, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.

All qualified candidates are encouraged to apply; however Canadians and permanent residents will be given priority.