Clinical Research Coordinator - Jobs in British Columbia

Job Description

Staff - Non UnionJob CategoryM&P - AAPSJob ProfileAAPS Salaried - Research and Facilitation, Level AJob TitleClinical Research CoordinatorDepartmentWood Laboratory Division of Cardiology | Department of Medicine | Faculty of MedicineCompensation Range$4,688.67 - $6,754.00 CAD MonthlyThe 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 DateNovember 10, 2022Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.Job End DateDec 5, 2022Job SummaryAssist in coordinating clinical research trials at CCI-CIC in accordance with approved research protocols and ethics guidelines, and act as a member of an interdisciplinary team conducting research.Organizational StatusThe Clinical Research Coordinator will report to the Research Manager. The position will work closely with other staff to fulfill the operational requirements of the research group.Work PerformedRegulatory Coordination

• Prepares documents required for initial research application submission for the local REB in an accurate and timely manner
• Prepares, facilitates, submits, and maintains the process of REB post-approval activities including, protocol amendments, administrative changes, SAE reporting, study close out, changes in the informed consent, or to enrollment as required by the federal regulations and internal policy
• Coordinates all aspects of REB submissions, including evaluating the protocol changes and incorporating those changes into the informed consent form in language understandable to participant
• Assists preparation of documents for REB including but not limited to: Addendums, Investigator’s Brochures, Safety Information
• Ensures that all documents submitted to REB are complete, and that the submission packet meets the REBs submission requirements
• Obtains all necessary signatures for regulatory documents for REB, VCHRI, PHCRI
• Responsible for communication and follow up to queries of the REB, sponsor, and other committees
• Maintains and accurately files all regulatory documents and necessary logs
• Manages the archival of clinical trial documents/records on site or off site for long term storage
• Collaborates with study coordinators to prepare regulatory and clinical documents for monitoring visits and audits
• Ensures that the regulatory files are current prior to monitor visits.
• Maintains current, signed versions of Investigator and staff Curriculum Vitae, medical licenses, nursing licenses, and Good Clinical Practice (GCP) certifications
• Maintains confidentiality of sponsor protocols and related documents.
• Creates error free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.)

Coordinating Research Studies

• Study start-up & close-out:
  • Attends site initiation visits for new studies
  • Assists in designing quality tools to aid in protocol implementation including: creating source documents and checklists, and designing case report forms and test worksheets
  • Conducting the close out of the study ensuring proper storage according to regulatory requirements
• Communication:
  • Liaise with internal and external sources to obtain required research approvals
  • Create and maintain excellent working relationship with hospital and research staff to ensure smooth running of clinical trials and patient’s safety
  • Communicating and coordinating clinical trial activity on PI and research team’s behalf
  • Provide documentation to patients and other health care professionals about the research protocol
• Research staff support:
  • Support research staff to ensure compliance is maintained while participants are on trial protocols, and act as a resource to research staff and colleagues when patients are enrolled in a study
  • Participate in study coordinator meetings and training sessions
• Compliance:
  • Complete all work according to FDA/Health Canada standards and Good Clinical Practice (GCP) Guidelines
  • Maintains patient confidentiality
• Patient screening:
  • Assists with assessing patients in the clinic(s), acute care wards, intensive care units, operating rooms and the emergency room for entry into clinical research studies based on very specific inclusion and exclusion criteria
  • Reviews existing medical records regularly
  • Aids with implementing recruitment strategies, coordinating and conducting patient recruitment, identifying, screening, bookings and enrolling suitable patients into studies.
• Participant consenting and enrollment:
  • Providing participant education on study background, purpose, procedures and potential benefits and risks
  • Able to travel to Vancouver General Hospital, St. Paul’s Hospital, and potentially to UBC Hospital sites to consent participants
  • Reviews and conducts the informed consent discussion with participants
  • Able to use a wide varied of web-based, application, or database tools to enroll patients onto a trial, potentially urgently to ensure patient has access to trial procedures, medications, or devices as a part of their clinical care
• Study implementation:
  • Ability to collaborate on many different study protocols across a variety study types: Phase 1/2, Phase 3, registry, prospective and retrospective investigator-initiated studies
  • Prepares and follows up on initiatives or issues relating to research and clinical trials
  • Managing study supplies, maintains inventory
  • Identifies and troubleshoots any problems and informs leadership in resolving any situation.
  • Contribute completion and confidentiality of the study including preparing for audits by sponsor and/or regulatory authority
• Data collection:
  • Collecting of study data (clinical & imaging) from electronic medical records, hospital charts, during procedures, etc.
  • Assists with collection, processing, storage, and shipping of study biospecimens
  • Entering research data into Case Report Forms and uploading images
  • Reviewing data results and consult leadership accordingly
  • Resolving any data related queries.
• Participant management
  • Coordinating research subject treatment/tests with various departments, pharmacy, physicians and other study staff personnel under the guidance of senior staff
  • Administers various study related questionnaires to participants according to study protocol
  • Informing senior staff of any Serious Adverse Events experienced by patients during the trial
  • Obtain appropriate related data and follow up on Serious Adverse Events

Consequence of Error/JudgementLack of careful attention to regulatory guidelines and approvals 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:1) personal: maintaining professional behavior and respect for subjects and staff 2) local: the UBC Clinical Research Ethics Board 3) Provincial: B.C. Privacy Act 4) Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and 5) International: U.S. Food & Drug Administration.In addition, PI will rely on the coordinator to alert them to clinical problems and unexpected events concerning study subjects and trial conduct: 1) Lack of study enrollment and completion of work according to deadlines would threaten loss of funding and consideration for future invitations to participate in clinical trials and 2) Poor communication skills with subjects would jeopardize their participation, and with sponsors and referring/community physicians could reflect badly on the reputation of the research group.Supervision ReceivedWork closely with the Clinical Research Nurse, Project Managers, Research Manager, Director of Research Operations, and each study Principal Investigator (PI), as part of a collaborative team. Work with general direction and minimal supervision from the study PI and other staff. This individual will be expected to work independently in accordance with established objectives; and exercise initiative and judgment in performing all work-related function.Supervision GivenNoneMinimum QualificationsUndergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.Preferred Qualifications

• 2+ year’s recent experience as a research/study coordinator for large industry, investigator-initiated studies, or clinical trials
• Experience with research ethics boards, participant screening, clinical data collection, monitoring / auditing preferred
• Nursing experience or recognized certification in clinical research (ACRP or SOCRA) preferred
• Registration with BC College of Nurses and Midwives (BCCNM) an asset
• Knowledge and certification of Dangerous Goods, ICH/GCP guidelines preferred
• Project management skills preferred
• Strong analytical and problem-solving skills preferred
• Demonstrated ability to express complex technical concepts effectively
• Strong verbal and written communication skills are asset
• Knowledge of applicable legislative, UBC and/or departmental policies and procedures preferred
• Client service oriented, with the ability to effectively work with diversity
• Computer competency in clinical applications, Microsoft products, databases, and the ability to adjust to new tools as they are implemented
• Physical ability to perform the duties of the position

UBC hires on the basis of merit and is strongly committed to equity and diversity within its community. We especially welcome applications from visible minority group members, women, Aboriginal persons, persons with disabilities, persons of minority sexual orientations and gender identities, and others with the skills and knowledge to productively engage with diverse communities. Canadian and permanent residents of Canada will be given priority.Diversity, equity and inclusion are essential to delivering exceptional care and building a great place to work. At CCI, we value and accommodate unique differences to ensure that our staff and medical staff – both current and prospective – have the opportunity and are supported to thrive.To build a strong and representative workforce, we are seeking candidates who will contribute to a caring and inclusive culture. We encourage applications from members of communities that are disadvantaged on any grounds under the B.C. Human Rights Code, including Indigenous Peoples, people of colour, people of all genders and sexualities and people with disabilities.Quick Apply

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