Clinical Research Nurse

Job Summary

The Research Nurse works in collaboration with the Research Coordinators, Research Assistants / Techs, and other Research Nurses to conduct clinical trials focused on supporting Multiple Sclerosis (MS) & NMO research.

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

Reporting to the Principal Investigator of the research or designate, the Research Nurse is responsible for reviewing research protocols and study design with Study Investigator(s), screening, registration, assessment and ongoing follow-up of research subjects in accordance with study protocols.

Obtains participant data and completes case report forms, charts and other study documentation. Supports department / program personnel to ensure study requirements are met.

May collect biological samples and review test results, as applicable.

Organizational Status

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 Point Grey Campus).

Work Performed

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

Implementing and educating study staff on study protocols.

Drafting and reviewing subjects Informed Consent Forms.

Reviewing and educating staff on subject safety measures.

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

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

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

Acting as a liaison with Research Manager, Principal Investigator (PI), sponsors and Contract Research Organizations (CROS).

Managing study supplies and maintaining inventory.

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

Maintaining quality documentation on research subjects (i.e. source documents, Case Report Forms CRF / eCRFs ), and resolving queries in a timely manner.

Designing data collection tools (e.g. source documents) in conjunction with the Research Coordinators and ensuring accurate and timely data collection and reporting to the Investigator and study Sponsor.

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 ICH-GCP guidelines.

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

Attending investigator meetings, teleconferences and education / workshop sessions.

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

Communicating study related activity with (UBC and VGH) nursing staff, laboratory staff, and Pharmacy staff.

Other tasks

Traveling as required to attend meetings and conferences.

Assisting with recruitment of study nurses.

Assisting with the training of research nursing staff.

Key contact for subject recruitment.

Acting as a blinded interviewer for studies as required.

Assisting in training research support staff.

Performing other related duties as required to meet study goals and timelines.

This position is situated in the Djavad Mowafaghian Centre for Brain Health. 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.

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 other Research Nurses, Research Manager, Research Coordinators and CROs.

Supervision Given

The Research Nurse advises Research Coordinators, Research Assistant / Techs, contracted service providers, laboratory staff and UBC / VGH laboratory staff, who are involved with the subjects and / or study conduct.

Minimum Qualifications

Registered Nurse with BCCNPplus a minimum of one year of nursing 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 to equity diversity and inclusion

Preferred Qualifications

Education, Training and Experience

Experience in a clinical position, preference for Neurology and / or chronic disease experience

Skills and Abilities

Effective interpersonal, oral and written communication, apply decision making and analytical skills, organization and problem-solving skills.

Ability and proven experience maintaining accuracy and attention to detail and working 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 if required.