VCHRI CRU Research Facilitator - Jobs in University of British Columbia (Vancouver campus), BC

Job Description

Staff - Non UnionJob CategoryM&P - AAPSJob ProfileAAPS Salaried - Research and Facilitation, Level AJob TitleVCHRI CRU Research FacilitatorDepartmentClinical Research Unit | Vancouver Coastal Health Research Institute | Faculty of MedicineCompensation Range4,688.67 - $6,754.00 CAD MonthlyPosting End DateNote: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.Job End DateThis position is expected to be appointed by promotion/reassignment and is included here to inform you of its vacancy at the University.Job SummaryThe VCHRI CRU Research Facilitator is responsible for providing support to clinical investigators for all aspects of pre and post review of ethics submissions and assisting with a range of general research activities in the Vancouver Coastal Health Research Institute Clinical Research Unit (VCHRI CRU). These duties include the day to day running of the VCHRI CRU involving planning, coordination, implementation, evaluation, communication and management of research studies. Some researchers only require assistance with a few responsibilities while others ask for assistance related to their entire study from start to finish. Researchers enter into an agreement with the VCHRI CRU at the outset to outline the various levels of service needed from the VCHRI CRU as they relate to sponsored clinical trials, investigator initiated and grant funded trials. Multiple trials are always underway at any given time.Organizational StatusThe Research Facilitator reports to the Director, VCHRI CRU Clinical Research Unit. The Facilitator will interact with other members of the VCHRI CRU/research teams as well as other hospital groups & health care professionals including clinicians/researchers, coordinators, students, sponsors, auditors, volunteers and study participants.

• Work Performed
• Provides leadership in the on-going development of the VCHRI CRU.
• Advises investigators on policy/processes and procedures and/or prepares regulatory document requirements.
• As requested obtains or assists investigators with ethics submissions/approvals for sponsored clinical trials, investigator initiated and grant funded trials. Includes providing advice/guidance to clinical research staff at all levels (from physicians to coordinators) on the UBC Research Ethics Board (REB), university, health authority, TCPS 2 policies, Health Canada, etc policies and procedures.
• Ensuring development, implementation, and adherence to all organizational and clinical standard operating procedures across all research programs.
• Plans and organizes clinical trials in accordance with good clinical practice guidelines (GCP).
• Experience with using UBC RISe (Research Information Systems) in order to submit ethics applications. Develops and/or prepares documents and relevant information required for the ethics submissions/approval. May include some or all (depending on the researcher s contract arrangement with VCHRI CRU) of the following: Assists with and/or writes ethics applications by interpreting research proposals/protocols & sponsor contracts/agreements, writes telephone scripts, advertisements, amendments, case report, deviations and adverse events reports, source documents, responds to provisos, identifies/determines relevant signatories depending on organization (UBC, VCH, external), faculty, centre and/or dept, division, coordinates payment to ethics review board, communicates results/outcomes and complete and/or provide various forms required to be completed by the PI and/or funding sponsor. Updates UBC RISe application when amendments and annual renewals are required to be submitted.
• Develops and oversees study progress, including recruitment, data collection and analysis safety, assessments, tracking of Adverse Events, Serious Adverse Events and protocol deviations. Resolve concerns relating to the research undertakings that may be expressed by taking direct action to address issues in a timely manner and/or bringing them to the attention of the study investigators.
• Completes the VCH Request for Approval to Conduct Research applications by determining which hospital services are required (may be single or multiple services) for each specific protocol/clinical trial (i.e. such as a requirement to use VCH Radiology for various scans, obtain tissue samples, OR space, nursing time, etc), submitting and obtaining relevant approvals for each service and ultimately obtaining overall approval to proceed with the study from VCHRI Clinical Trials Administration Office. Responds to requests for clarification, additional information, amendments, etc.
• Interprets requirements for Investigator-initiated studies where there may or may not be a funding agreement in place. Ensures proposals are complete and meet regulatory requirements.
• Determines participant suitability for studies, explains study parameters, rights and responsibilities of each party and consents research participants in accordance with ethics and regulatory requirements.
• Performs various services/procedures depending on protocol requirements including but not limited to venipuncture, vital signs (such as blood pressure and temperature monitoring), processing, shipping, of blood samples in accordance with regulatory requirements (TDG), etc.
• Trains and orients new staff.
• Writes VCHRI CRU procedures as required for study visits and procedures.
• Prepare and participate in monitoring and regulatory agency visits.
• Operates a variety of equipment such as but not limited to centrifuges, incubators, weight scales, sensaphone, etc and monitors fridges and freezers to ensure temperatures meet min/max requirements to comply with regulatory and/or study requirements.
• Follows regulatory guidelines for storage of samples by following SOP s regarding power outages, shipping/receiving samples including TDG, addressing equipment failures and maintaining/documenting yearly calibrations.
• Participates in departmental training programs (of the VCHRI CRU) in all aspects of research updates.
• Coordinates multiple studies concurrently and tracks projects/services for billing purposes.
• Coordinates with hospital departments and staff to ensure compliance with protocol requirements
• Reviews and performs VCHRI CRU quality assurance.
• Facilitates internal and external meetings as required. Attends or holds regular status meetings with project teams.
• Performs other related duties as required and assigned.

Consequence of Error/JudgementThe Research Facilitator must perform duties according to GCP guidelines and be independently motivated, organized, and detailed oriented. The Research Facilitator is required to conduct all research activities in an ethical manner, suited to the proper activities of the University of British Columbia and those governing the activities of the institution. Any procedures or data recorded must be accurate and must accurately reflect the work performed. Strict confidentiality of all study participants must be adhered to. Breaches in confidentiality, inattention to detail, and data entry errors could have significant effect on the integrity of the research, which could impact funding and the reputation of Investigators and the VCHRI CRU. This position requires firm adherence to deadlines; missed deadlines could result in lost time and potentially significant financial implications with respect to research progress. All activities involving participants are accountable to the VCHRI CRU Director.Supervision ReceivedThe Research Facilitator works under general direction of the Director, Clinical Research Unit within established policies, procedures and standards. Work reviewed against task objectives and conformity to standards.Supervision GivenThe Research Facilitator provides guidance with respect to ethics guidelines and regulations. He/she will also assist with orientation and training of new staff, students, visitors and volunteers.Minimum QualificationsUndergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience. Undergraduate degree in a relevant discipline.Preferred QualificationsNursing Diploma an asset. GCP Certified. Certificate in venipuncture required. Basic knowledge of other health care disciplines and their role in client care preferred. Comprehensive knowledge of UBC Research Ethics Board, (REB) and Tri-Council Policy (TCPS2). Experience with using UBC RISe (Research Information System) in order to submit ethic applications. Training in WHMIS, Chemical Safety, Biological Safety and Transportation of Dangerous Goods required. Ability to operate job-related equipment (e.g. incubators, centrifuges, etc.) Ability to conduct job-related interviews to obtain accurate, complete, and relevant information in order to determine suitability for studies and, where applicable, obtain patient consent. Experience in research or clinical trials. Working knowledge of lab operations. Ability to determine the nature and urgency of inquiries and issues, and triage appropriately. Ability to exercise sound judgment. Ability to triage/prioritize and work effectively under pressure to meet deadlines. Ability to effectively manage multiple tasks and priorities. Ability to be thorough, accurate and have a high level of attention to detail. Ability to analyze and interpret data, determine implications, and provide recommendations. Ability to understand and apply policies, procedures, and instructions. Demonstrated ability to be independently motivated, organized and detail oriented. High ability to communicate effectively verbally and in writing. Ability to perform research-related procedures (e.g., administer blood draws, prepare solutions, dissections, specimens).Ability to exercise tact and discretion and maintain confidentiality. Ability to work effectively independently and in a team environment. Ability to listen actively and attentively, and obtain clarification as required .Ability to effectively use RISe and MS Outlook, MS Word, MS Excel and the internet an intermediate level. Ability to learn various hospital applications where needed. Ability to respond appropriately to inquiries in person, on phone, and in writing, in a calm, courteous manner. Ability to accurately create and maintain recordsQuick Apply

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