Job type: Full-time

Salary: $4,689–$6,754 a month

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Job content

Staff - Non Union
Job Category
M&P - AAPS
Job Profile
AAPS Salaried - Research and Facilitation, Level A
Job Title
Research Coordinator
Department
MS Clinical Trials Support Division of Neurology | Department of Medicine | Faculty of Medicine
Compensation Range
$4,688.67 - $6,754.00 CAD Monthly
The 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 Date
August 11, 2023
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date
Aug 14, 2024
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 position is expected to be filled by promotion/reassignment and is included here to inform you of its vacancy at the University.
At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.
Job Summary
Responsible for planning, organizing, implementing and coordinating the activities of clinical research projects for the Multiple Sclerosis (MS) and Neuromyelitis Optica (NMO) Clinical Trials Group. Responds as required to the informational needs of potential subjects, health care workers, and the public regarding MS and NMO research.

Working Conditions:
This position is situated in the Djavad Mowafaghian Centre for Brain Health (DMCBH) - UBC Vancouver campus. Working conditions consist of locked office with office furnishings and a networked PC and Internet environment.

In addition to areas of the hospital, outpatient visits are performed in clinical offices, and research recording and communication occurs within the research office. Attendance at study meetings within the hospital, and travel to national/international conferences and study meetings occur several times a year.

Organizational Status
Reports to the Research Manager, working under the Direction of the Program Manager. Liases, in conjunction with Principal Investigator(s), research ethics committees and Pharmaceutical Company representatives or funding sources who are initiating or monitoring research studies.

Work Performed
. Implementing study procedures in accordance with research protocols.
. Screening and recruiting research subjects and devises strategies for effective recruitment.
. Providing patient education on study background, purpose, procedures and potential benefits and risks.
. Conducting subject clinical, behavioral and neuropsychological assessments.
. Training junior staff and/or student volunteers as required.
. Preparing submissions to the Clinical Research Ethics Board.
. Ensuring Accurate and timely data collection and response to study queries.
. Organizing collection, storage and shipment of biomarkers in collaboration with Research Assistant/Tech. staff.
. Organizing and prioritizes workload to meet the study deadlines and sponsor queries/requests.
. Acting as a key liaison with Research Manager, Principal Investigator (PI), sponsors and Contract Research Organizations (CRO S).
. Managing study supplies, maintaining inventory and is accountable to the Investigator, sponsor and federal regulatory bodies as per GCP guidelines.
. Creating and maintaining quality documentation on research subjects: source documents, Case Report Forms (CRF/eCRF s), resolving queries in a timely manner.
. Ensuring study conduct with adherence to ICH-GCP, FDA and Health Canada Div. 5 guidelines.
. Informing the investigator of the clinical progress of the study subjects.
. Meeting with pharmaceutical company representatives, consultants and Contract Research Organizations (CROs) for trial initiation, maintenance and monitoring of subjects visits.
. Transmitting study data to sponsors with strict adherence to privacy and confidentiality guidelines (GCP).
. Ensuring enrolment expectations are met.
. Ensuring collection of appropriate subject samples including blood, urine and cerebrospinal fluid.
. Assisting with health assessment report collection (bloodwork, MRI, Dermatology. Ophthalmology etc.).
. Carrying out research functions including checking subject history, conducting interviews, completing questionnaires, making observations and assessing subjects.
. Informing the Research Manager, Investigator, Research Ethics Board and sponsor of any Serious Adverse Events experienced by subjects during the trial.
. Communicating regularly with the help desk teams of different sponsors to address technical problems on site or with study devices.
. Responding to and answering subject questions, concerns, and problems (general study related questions [non-health related]).
. Conducting the close out of the study ensuring proper storage according to regulatory requirements.
. Monitoring subject progress: Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.
. Attending investigator meetings, teleconferences and education/workshop sessions.
. Communicating and coordinating study related activity with (UBC and VGH) MS Clinical Trials staff, nursing staff, laboratory staff, pulmonary function, Pharmacy staff, and MRI staff.
. Developing study source documentation to meet both study site and study protocol requirements.
. Paying strict attention to detail, maintains a high level of organization and a strong commitment to meeting study timelines.

Other tasks:
. Traveling as required to attend meetings and conferences.
. Assisting in subject recruitment for studies
. Acting as a blinded interviewer for studies as required
. Acting as a backup coordinator for other studies with other PIs when necessary
. Maintaining education and training on ICH-GCP, Health Canada Div. 5, research involving human subjects Standard Operating Procedures and trial related training.
. Performing other related duties as required to meet study goals and timelines.

Consequence of Error/Judgement
The coordinator is responsible for:

a) Lack 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.

b) Clinical mistakes made by the coordinator could be life threatening to subjects. Ensuring subject safety includes: 1) accurately judging study eligibility 2) being prepared for any side effects (expected or unexpected) and 3) updating clinical skills and knowledge to meet the demands of clinical complexity.

In addition, the Research Manager and PI 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 would reflect badly on the reputation of the research group.

Supervision Received
Training and supervision for the Research Coordinator will be provided by the Research Manager. Reports directly to the Research Manager. The PI and/or his/her designate will provide broad directives. The coordinator collaborates with the Research Manager and CRO s.

Supervision Given
The coordinator advises/educates nurses, other research staff, contracted service providers, laboratory staff and UBC/VGH laboratory staff, who are involved with the subjects or study conduct on the study protocol(s). The coordinator also acts as a resource with hospital staff, subjects and colleagues, and manages subject progress and follow-up.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.

  • Willingness to respect diverse perspectives, including perspectives in conflict with one’s own
  • Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion
Preferred Qualifications
Knowledge of current research regulatory guidelines (ICH-GCP, Health Canada Div. 5, research involving human subjects) and standards is preferred. Experience with psychometric testing and knowledge of standard neuropsychological tests required. Working knowledge of research methodology and design. Ability to exercise judgement and make decisions in accordance with the broad research objectives. Ability to independently organize workload. Computer proficiency mandatory, including use of Word and Excel spreadsheets and similar applications. Knowledge of statistical methods and database applications is an asset. Effective interpersonal, oral and written communication, organization and problem-solving skills. Ability to maintain accuracy and attention to detail and to work effectively under pressure to meet deadlines. Ability to work both independently and within a team environment. Ability to exercise tact, discretion and diplomacy. Availability for some after-hours and week-end work required
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Deadline: 17-03-2024

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