Location:Vancouver –BC Children’s Hospital

Employment Group:ManagementProfessional (AAPS)

Business Title:TRACE and CAR-T Cell Program Manager

VP/Faculty:UBC, Faculty of Medicine, Dept of Paediatrics

Salary Range:$64,402.00 (minimum) - $77,314.00 (midpoint) - $92,778.00 (maximum)

Full/Part Time:Full-Time

Desired Start Date:09/05/2017

Job End Date:09/04/2018

Funding Type:Grant Funded

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

Job Summary

The position is responsible for two projects with 50% responsibility to each.

a. 50% of the position will be dedicated to acting as the TRACE Program Manager with responsibility for the management and logistical oversite of the Transplantation & Cell Therapy research program (TRACE) at BC Children's Hospital (BCCH). This is a large multi-site, multi-project program involving both laboratory and clinically based research as well as biomarker development and cell therapy applications for patient care.

b. 50% of the position will be dedicated to the Michael Cuccione Childhood Cancer Research Program (MC3RP) CAR-T cell project. The position will be responsible for BCCH participation in CAR-T cell clinical trials through the CureWorks consortium and the Cancer Immunotherapy Trials Network (CITN). The position will be responsible for development of a business plan, contract, Health Canada compliance, ensuring good clinical practice and Foundation for the Accreditation of Cellular Therapy (FACT) compliance with training of clinical and laboratory trials physicians and staff, and will work with the Michael Cuccicone Childhood Cancer research program clinical trials unit (CTU).

The work will be done at BC Children's Hospital Research Institute, in a standard office environment. Lab spaces are likely to be directly adjacent to the office area. Successful completion of UBC's Biological Safety and Human Research Ethics Courses are required. The subject should be immunized against hepatitis B, tetanus and all normal childhood vaccines. The majority of the working hours will be between 9 am and 5 pm, 5 days a week. However, responsibilities may require work outside of these hours.

Organizational Status

The position will have a dual reporting mechanism:

The TRACE Program Manager role will work with faculty, staff, and trainees at BC Children's Hospital and will report to a Management Committee. For specific infrastructure and projects within the TRACE program, the TRACE Program Manager role will work with the Faculty leads to ensure goals and timelines are met. The TRACE Program Manager will also collaborate and work with external staff at participating organizations, hospitals and collaborating laboratories located at different sites nationally and internationally.

The MC3RP CAR-T cell project manager role will report to the MC3RP director and cell therapy processing facility director. The role is expected to work collaboratively with the MC3RP CTU Manager, Clinical Research Manager, and Blood and Marrow Transplantation (BMT) team, and MC3RP developmental therapeutic program to develop all aspects of the CAR-T cell trials. The position will also administer aspects of the CAR-T cell trials directly related to TRACE program clinical trials reporting and performance. The incumbent will also be expected to work with the C17 regulatory office in relation to Health Canada requirements.

Work Performed

Team Coordination:

  • Work with TRACE stakeholders to implement TRACE business plan.
  • Will develop, in conjunction with the MC3RP director, and implement the MC3RP CAR T cell program.
  • Will coordinate with the MC3RP CTU Manager, Clinical Research Manager, cell therapy technologist, and BMT managers.
  • Will work with the CureWorks and CITN for opening clinical trials, performance, and monitoring.
  • Organize team communication at various levels, including setting meeting agendas, taking minutes and tracking action items.
  • Liaise with the BC Children's Hospital Foundation and key donors for reporting and updates.
  • Communicate regularly with project investigators and relevant staff at BCCH to track progress and anticipate/solve problems.
  • Liaise with external sites' project coordinators for each component of the TRACE program and ensure teams are working effectively with each other.
  • Ensure standard operating procedures and quality control standards are met as needed.
  • Organize and lead communication with personnel external to BCCH.
  • Performs other responsibilities, as required.

Managing Logistics:

  • Will work with the C17 regulatory office in relation to Health Canada regulatory issues.
  • Will work with the MC3RP CTU, BMT Manger, and Cell therapeutics laboratory ensure the program is GCP and FACT compliant.
  • Will work collaboratively with the Manager of the Transplantation Applied Biomarker Laboratory to procure Diagnostic Accreditation Program (DAP) approval and maintenance.
  • Liaises with the Research Ethics Board and associated hospital departments to prepare applications, obtain approvals for multiple projects, and oversee compliance with approved protocols.
  • Organize and manage contracts as needed, purchasing of equipment and supplies, and necessary training for staff.
  • Design and manage research budgets and liaises with funding agencies/foundation to coordinate financial reporting.
  • Implement and oversee mechanisms for bio-sample collection and storage.
  • Implement and monitor RedCAP based clinical data collection forms and data integrity.
  • Work with statisticians to transfer data for analysis and eventual knowledge translation.
  • Works with designated Institute staff to ensure necessary space and resources for the projects and related personnel.
  • Works to establish collaborations needed to support project deliverables.
  • Perform other responsibilities, as required.

Staff management:

  • Supervision of TRACE-employed staff and trainees.
  • Co-supervision of a MC3RP CRA and cell therapy technologist associated with CAR-T cell program and TRACE cell therapeutic program.
  • Performs other responsibilities, as required.

Research and Reporting:

  • Develop management plans for research projects, including milestones for funding, proposal development, completion, presentation and publication; communicating and coordinating research projects to ensure that priorities and timelines are accomplished.
  • Design research methodology in conjunction with MC3RP and TRACE faculty leads, including questions and approaches for projects; critically reviews the literature on a regular basis.
  • Performs study/project design, data analysis, and manuscript preparation.
  • Manage regulatory reporting and accreditations, and ensure regulatory requirements are met and maintained.
  • Direct the organization and maintenance of research data; analyses and coordinate presentations of complex data in meetings and for publications.
  • Develop new research directions in collaboration with the research team.
  • Develop grant applications and explore opportunities to secure additional funding in order to sustain the programs.
  • Performs other responsibilities, as required.

Supervision Received

For TRACE projects this position will report to a TRACE Management Committee and also works closely with Childhood Diseases and Biobank administration. For specific projects the Program Manager will work with the Biomarker Program and Cell Therapy Program Faculty leads. The TRACE Program Manager is expected to work under limited supervision and exercise considerable judgment and initiative in duties and responsibilities. For MC3RP CAR-T cell activities the position will report to both the MC3RP and cell therapy processing facility directors.

Supervision Given

Provides supervision and management of all TRACE staff and trainees, with more direct management of Research Coordinator positions, who in turn directly manage technical staff in their facilities.

Consequence of Error/Judgement

Failure to plan or follow up on initiatives and poor judgment or errors dealing with such matters would have an adverse effect on the TRACE program's productivity and operational management. Inability to work in a collaborative and facilitative way will have a negative impact with collaborators and donors. Ability to exercise sound judgment in dealing with administrative matters where there are no established policies, procedures or guidelines is essential. Failure to act in a professional, tactful manner will have an adverse effect on campus and community relations.

Qualifications

Post-graduate degree or equivalent professional designation if responsible for a research project otherwise Undergraduate degree if not responsible for a research project. Society of Clinical Research Associates (SOCRA) certification is preferred. 4 years or equivalent combination of education and experience if responsible for research project otherwise 6 years or equivalent combination of education and experience if not research work. Experience managing large scale research projects; including writing protocols, developing SOPS, contracts, ethics, budgets, regulatory issues and performance of clinical trials, grant preparation, manuscript drafting. Experience in clinical research and a research hospital environment. Excellent time management and project management skills.

Effective oral and written communication, interpersonal, and problem-solving skills. Ability to exercise appropriate tact, discretion, confidentiality, and good judgment in all matters.

Ability to work independently with appropriate initiative, as well as effectively with others in a team environment.

Ability to work accurately, and under pressure to meet deadlines.

All positions in the Department of Pediatrics at BC Children's Hospital require a Criminal Record Check (CRC). A pre-employment CRC is required as part of the recruitment process and any offer of employment is contingent pending positive results of the CRC.

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.

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