UBC: Research Services Manager (Hem/Onc/BMT)

Open until filled
No
Closing date
Internal / External
External to BC AHSN
Job type
Full time
Location
Vancouver Coastal Health Region
How to apply

Please submit your application directly to UBC

Apply here

 

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Staff - Non Union

Job Category

M&P - AAPS

Job Profile

AAPS Salaried - Research and Facilitation, Level C

Job Title

Research Services Manager (Hem/Onc/BMT)

Department

Maxwell Laboratory | Department of Paediatrics | Faculty of Medicine

Compensation Range

$5,906.25 - $8,508.42 CAD Monthly

Posting End Date

November 30, 2021

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

Job End Date

Jan 31, 2023

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.

This offer is conditional upon successful completion of a Criminal Record Check.

Job Summary

This position is responsible for the start-up and initiation of clinical trials conducted by the Michael Cuccione Childhood Cancer Research Program (MC3RP) within the Clinical Trials Unit (CTU) of the Children's and Women's Health Centre of BC's Division of Hematology/Oncology/Bone Marrow Transplant (Hem/Onc/BMT) – the “Division” - and the BC Children's Hospital Research Institute.

The MC3RP program supports approximately 100 active clinical research studies for children and young adults in British Columbia with cancer and blood disorders. These studies include, but are not limited to, research on active treatment, supportive care, and the long-term effects of cancer related illnesses, cellular transplant, and blood disorders therapy.

The MC3RP has a number of research affiliations that include CureWorks, Transplantation and Cellular Therapeutics (TRACE), Pediatric Cancer Immunotherapy Trials Network (PedCITN), The Blood and Marrow Transplant Clinical Trials Network (BMT CTN), Industry Sponsors, Primary Immune Deficiency Treatment Consortium (PIDTC) Children's Oncology Group, the C17 Council for Childhood Cancers and Blood Disorders, Precision Oncology For Young people (PROFYLE), Canadian Cancer Trials Group (CCTG), Pediatric Blood and Marrow Transplant Consortium (PBMTC), Centre for International Blood and Marrow Transplant Research (CIBMTR), Canadian Bone Marrow Transplantation Group (CBMTG) as well as investigator-initiated research. Expansion beyond the existing relationships is ongoing.

The primary function of the position is to contribute strategic vision to all research activities conducted within the Division and oversight to staff performing ethics and regulatory research activities, including start up and study maintenance, within the Division. The individual will be accountable along with the CTU Manager for the start up and execution of clinical protocols within the allocated budget, personnel resources and timelines.

The incumbent is required to conduct all research activities in an ethical manner, suited to the regulations of the University of British Columbia and to the professional organizations governing them and those governing the activities of the institution and all other investigators. Any procedures undertaken as part of this position must follow applicable regulatory guidelines. Strict confidentiality of all study matters must be adhered to. The incumbent's research activities are accountable to the interim Research Director.


Organizational Status

This position reports directly to the interim Research Director.  Additionally, the incumbent will liaise directly with investigators within the Division, Liaising directly with physicians and staff in the Hematology/Oncology/BMT clinical research offices as well as other departments within the Children's and Women's Health Centre and the BC Cancer Agency. The manager will also collaborate and work with external staff at participating organizations, hospitals and collaborating laboratories located at sites both nationally and internationally.

The incumbent's office is located in the Oncology laboratory area of BC Children’s Hospital Research Institute (BCCHRI) South Building.


Work Performed

  • Responsible for the overall management and support of the Clinical Research Associate (CRA) start-up group; prioritization and assigning of work for all studies.

  • Responsible for the hiring, oversight and evaluation within the CRA start-up group in collaboration with the CTU Manager.

  • Manages the clinic trials start-up group to ensure preparation, submission and maintenance of REB and departmental related documentation for a diverse number of protocols

  • Manages the clinical trials start-up group regarding the writing, preparation and amendments of ethics applications and other regulatory documents required by Health Canada and the FDA.
    Manages the clinical trials start-up group ensuring that trials will be maintained according to legal and ethical requirements.

  • Manage Research Nursing/Clinical Coordinator staff in the conduct of study activities

  • Responsible for continuing quality improvement.

  • Mentors department personnel outside the CTU (ie new investigators, medical trainees) in study start-up within Oncology/Hematology/ BMT.

  • Provides strategic leadership in the coordination and administration of the start-up activities of clinical trials to meet program objectives.

  • Over see and manage the Research Oversight (ROC) and Phase I.II Developmental Therapeutics (DVL) Committees, lead study specific unit meetings and participate in general staff training activities.

  • Over see and manage the Administrative CRA who maintains the Division research regulatory documents.

  • Facilitates operational linkages within and among co-investigators, clinic directors, physicians and other health care professionals within the hospital and medical community.

  • Ensures that there is up to date clinical trials start-up group training to align with GCP (Good Clinical Practice).

  • Responsible for protocol development for human clinical studies with local and external investigators.

  • Over see and manage pre-study evaluations of clinical trial site and study specific site initiation visits (SIV) including coordination of visits, correspondence with sponsor/sponsors' representative(s), and addressing issues raised.

  • Provide feedback on regulations and budget at study review meetings and throughout administration of clinical trials.

  • Provide feedback on proposed study protocol issues.

  • Liaise with the University/Industry Liaison Office (UILO) and BCCH Research Institute Finance Manager on contract related start-up and on-going issues.

  • Liaises with co-investigators, collaborators, the health care team and other research personnel both on-site and at national/international institutions for: project management, information exchange regarding assigned studies, and logistics to facilitate the operation of the studies.

  • Responsible for the organization and management of contracts and related communication between parties, budget reviews and negotiation, liaising with funding agencies/foundations, purchasing of equipment and supplies.

  • Manage the activities surrounding monitoring and auditing by regulatory bodies for assigned protocols including coordination with research staff, preparing for and participating in visits, and responding to action-items that arise.

  • Manage the activities surrounding the archiving of closed clinical research projects including trial file collection, organization, and storage by research staff and review to ensure compliance with regulatory standards.

  • Attend conferences and meetings, possibly involving travel, and perform other related duties as required.

  • Demonstrates communication and general behavior that facilitates positive attitudes toward participation in clinic research.

  • Oversee and manage accuracy, accessibility, and confidentiality of study records and reports.


Consequence of Error/Judgement

The most important feature of the CTU is that it is essential in its role to provide children and young adults with access to innovative treatment options.  Consequences of error are high as this is a position with significant responsibility. The activities described above impact the direction of Division program objectives. Errors have the potential to could influence the reputation of the program as a whole and jeopardize the options for collaborative participation with industry, government and other research centers.

Supervision Received

The Research Services Manager reports directly to the Interim Director of Clinical Research.   The incumbent will be required to problem solve on a continual basis. The overall supervision of the MC3RP program is headed by the Interim Director of Clinical Research who is responsible to the Hematology/Oncology/BMT Division Medical Head and Executive Director of the BCCHRI.

The Research Services Manager works closely with the CTU Manager to ensure that clinical research activities are accomplished seamlessly and within established operating principles.


Supervision Given
The Research Services Manager advises and directly supervises a diverse team, which includes clinical research associates, research RN and research coordinator roles.

Minimum Qualifications
For research work, a post-graduate degree or equivalent professional designation with a minimum of four years of related experience, or an equivalent combination of education and experience. Otherwise, an undergraduate degree in a relevant discipline is required with a minimum of six years of related experience, or an equivalent combination of education and experience.

Computer knowledge essential. Effective written, communication and interpersonal skills. Advanced organizational skills and ability to oversee the management of staff involved in multiple projects at various stages of development and organization.

Mandatory Requirements:

  • Ability to work both independently and effectively manage a changing team environment

  • Ability to motivate and lead a team with effective conflict resolution skills.

  • Extensive experience with the UBC RISe application process or similar on-line applications

  • Extensive knowledge of medical terminology

  • Extensive knowledge of ethical principles and research applications

  • Extensive knowledge of Canadian regulatory principles and legislation

Assets:

  • Demonstrated knowledge and experience with Pediatric Oncology, Hematology, BMT and Cellular Therapeutics

  • Attentive to detail, with the ability to work accurately and quickly

  • High degree of computer literacy including familiarity with Microsoft Word and Excel

  • Ability to learn new software programs

  • Excellent organizational and interpersonal skills a must

  • Ability to prioritize and work effectively under pressure to meet deadlines

  • Ability to maintain relationships with both clinical and technical staff.

  • Ability to exercise initiative and maintain confidentiality

  • Effective communication, both orally and in writing