Job Description

Staff - Non Union

Job Category M&P - AAPS

Job Profile AAPS Hourly - Nursing, Level B

Job Title Clinical Research Nurse

Department MS Clinical Trials Support Division of Neurology | Department of Medicine | Faculty of Medicine

Compensation Range $38.86 - $55.98 CAD Hourly

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 February 1, 2023

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

Job End Date Jan 30, 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.

Job Summary
The Research Nurse works in collaboration with the Research Coordinator s, Research Assistant/Tech s, and other Research Nurses to conduct clinical trials focused on supporting Multiple Sclerosis (MS) research.

Organizational Status
The Clinical Research Nurse works under the direction of the MS Research Manager and is responsible to the MS Clinical Trials Group Director.

Work Performed

Under broad direction of the PI, this position performs the following duties:

\xc2\xb7 Evaluating new study protocols for suitability and/or safety, prior to site initiation.

\xc2\xb7 Implementing and educating study staff on study protocols.

\xc2\xb7 Drafting and reviewing subjects Informed Consent Forms.

\xc2\xb7 Reviewing and educating staff on subject safety measures.

\xc2\xb7 Planning, coordinating and conducting subject recruitment, screening, and enrolling suitable subjects into the study.

\xc2\xb7 Attending monthly information/education sessions for MS patients in the MS Clinic to provide information on currently recruiting clinical trials (studies).

\xc2\xb7 Obtaining and documenting subject informed consent as per Good Clinical Practice (ICH-GCP).

\xc2\xb7 Acting as a liaison with Research Manager, Principal Investigator (PI), sponsors and Contract Research Organizations (CRO S).

\xc2\xb7 Managing study supplies and maintaining inventory.

\xc2\xb7 Maintaining accountability to the Investigator, Sponsor and Federal regulatory bodies (Health Canada and the FDA) as per ICH-GCP guidelines.

\xc2\xb7 Maintaining quality documentation on research subjects (i.e. source documents, Case Report Forms [CRF/eCRF s]), and resolving queries in a timely manner.

\xc2\xb7 Designing data collection tools (e.g. source documents) and ensuring accurate and timely data collection and reporting to the Investigator and study Sponsor.

\xc2\xb7 Ensuring data collection tools meet the needs of the study site as well as the study protocol and study specific sponsor requests. Ensuring study conduct with adherence to ICHGCP guidelines.

\xc2\xb7 Recording study data with strict adherence to privacy and confidentiality guidelines (ICH-GCP).

\xc2\xb7 Participating in developing and evaluating strategies to meet the clinical trial goals and objectives.

\xc2\xb7 Working with the study team to ensure enrolment expectations are met.

\xc2\xb7 Ensuring collection of appropriate subject data as per study protocol, addressing sponsor queries in a timely manner.

\xc2\xb7 Independently carrying out research functions including checking subject history, conducting interviews and questionnaires, making observations, performing ECGs and assessing subjects.

\xc2\xb7 Informing Research Manager, Investigator and Sponsor of any Serious Adverse Events to subjects during the trial.

\xc2\xb7 Obtaining appropriate related data and follow up on Serious Adverse Events.

\xc2\xb7 Providing subject education on study background, purpose, procedures and potential benefits and risks.

\xc2\xb7 Dispensing study drug according to randomization number and maintaining study drug accountability and storage.

\xc2\xb7 Administering parenteral study medications and monitors subjects as appropriate during infusions.

\xc2\xb7 Ensuring appropriate notification to family physicians and/or specialists of subject s participation and of any change in subject s condition or abnormal test results and action taken by the PI.

\xc2\xb7 Communicating regularly with the study coordinator and other research staff to address technical problems on site or with subject devices.

\xc2\xb7 Responding to and answering subject questions, concerns, and problems (general and health related).

\xc2\xb7 Monitoring subject progress: Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.

\xc2\xb7 Educating subjects and their family and/or partners about study, medication, and potential serious adverse events.

\xc2\xb7 Attending investigator meetings, teleconferences and education/workshop sessions.

\xc2\xb7 Working with the study coordinators to meet deadlines for industry sponsors.

\xc2\xb7 Communicating study related activity with (UBC and VGH) nursing staff, laboratory staff, Pulmonary Function, Laboratory staff, Pharmacy staff.

Consequence of Error/Judgement

The Research Nurse 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 Research Nurse 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 Research Nurse 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
The position will perform duties independently. PI and/or his/her designate will provide broad directives. The Research Nurse collaborates with the Research Manager and CRO s.

Supervision Given

The Research Nurse advises Research Coordinators, other Research Nurses, Research Assistant/Tech. s, contracted service providers, laboratory staff and UBC/VGH laboratory

staff, who are involved with the subjects and/or study conduct.

The position must work independently and within standard and acceptable boundaries for ethical and competent research practice. The position will report to the Research

Manager and MS Clinical Trials Director, be accountable to the Principal Investigators as well as within the guidelines of Multiple Sclerosis Clinical Trials group staff practicing at

the Djavad Mowafaghian Centre for Brain Health (UBC Campus).

Minimum Qualifications
Research Nurse: Registered Nurse with BCCNP plus three years of nursing and administrative experience. Clinical Associate: Undergraduate degree in Nursing and Registered Nurse with BCCNP, plus at least two years of experience in a clinical position. Nurse Practitioner Clinical Associate: Postgraduate degree in Nursing and Registered Nurse with BCCNP, plus two years of experience in primary care NP practice or a combination of education and experience.

Preferred Qualifications

Current certification in basic CPR mandatory. Knowledge of current research regulatory guidelines and standards is preferred. Clinical experience in Neurology preferred.

Knowledge of current research regulatory guidelines and standards is preferred. Computer experience required including familiarity with word processing and spreadsheet

applications. Knowledge of statistical methods and database applications is an asset. Proven supervisory and leadership skills. Effective interpersonal, oral and written

communication, negotiation, 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.

University of British Columbia