Research Nurse Coordinator

Job Summary

The Research Nurse Coordinator supports and coordinates clinical trials within the Multiple Sclerosis (MS) & Neuromyelitis Optica (NMO) Clinical Trials Program at the Djavad Mowafaghian Centre for Brain Health (UBC Hospital). This role integrates specialized nursing practice with advanced clinical research coordination to ensure safe, ethical, and efficient conduct of investigator‑initiated, academic, and industry‑sponsored studies. The position requires independent judgment, strong clinical assessment skills, and the ability to manage multiple priorities in a fast‑paced research environment.

Organizational Status
Reports to the MS & NMO Clinical Trials Director and Research Manager. Works independently within established standards for ethical and competent research practice. Collaborates closely with Principal Investigators, Sub‑Investigators, Research Coordinators, Research Assistants, Research Nurses, CROs, sponsors, laboratory staff, pharmacy, imaging, and clinical departments at UBC and VGH.

Work Performed
Protocol & Study Start‑Up Responsibilities

• Evaluate new study protocols for feasibility, safety, and operational requirements prior to site initiation.
• Implement study protocols and educate research staff to ensure consistent and compliant study conduct.
• Draft and review participant Informed Consent Forms; support REB submissions, amendments, and renewals.
• Prepare regulatory start‑up documentation and ensure compliance with ICH‑GCP, Health Canada Division 5, FDA, TCPS2, and institutional policies.
• Act as a liaison with sponsors, CROs, and national/international study teams during initiation, maintenance, and close‑out.

Participant Recruitment & Engagement

• Plan, coordinate, and conduct participant recruitment, screening, and enrollment activities.
• Serve as a key contact for subject recruitment; develop and evaluate recruitment strategies.
• Attend monthly MS Clinic information/education sessions to provide patients with details on actively recruiting studies.
• Obtain and document informed consent according to ICH‑GCP and REB requirements.
• Provide education to participants and families regarding study background, procedures, investigational treatments, risks, and benefits.
• Respond to participant questions, concerns, and device‑related issues; support retention throughout the study.

Clinical & Nursing Responsibilities

• Independently conduct clinical assessments, vital signs, ECGs, interviews, questionnaires, and protocol‑specific procedures.
• Collect, process, store, and ship biological samples (blood, urine, CSF) according to protocol.
• Administer investigational products, including parenteral medications, and monitor participants during infusions.
• Dispense study drug according to randomization and maintain drug accountability and storage.
• Notify family physicians or specialists of participant involvement, abnormal findings, or PI‑directed actions.
• Maintain readiness for expected and unexpected adverse events and ensure participant safety throughout study participation.

Safety Monitoring & Adverse Event Management

• Monitor participant progress, adherence, and treatment response throughout study participation.
• Identify, document, and report adverse events and serious adverse events (SAEs) according to protocol and regulatory requirements.
• Obtain follow‑up information and communicate safety concerns to the Research Manager, Investigator, and Sponsor.
• Ensure appropriate escalation of clinical concerns and abnormal findings.

Data Management & Documentation

• Maintain accurate and complete study documentation, including source documents, regulatory files, and CRFs/eCRFs.
• Design data collection tools (source documents) to meet protocol, site, and sponsor requirements.
• Ensure timely data entry, query resolution, and strict adherence to privacy and confidentiality guidelines (ICH‑GCP).
• Transmit study data to sponsors and maintain investigational product accountability and study supply inventory.

Regulatory Compliance & Quality Assurance

• Ensure strict adherence to ICH‑GCP, Health Canada Division 5, FDA regulations, TCPS2, PIPA/PIPEDA, and UBC REB requirements.
• Support monitoring visits, audits, inspections, and quality improvement initiatives.
• Maintain current training in ICH‑GCP, SOPs, CTMS, and trial‑related competencies.
• Assist the Research Manager with training initiatives, including onboarding, SOP updates, CTMS training, and maintaining staff compliance with regulatory requirements.

Collaboration, Training & Team Support

• Work closely with Research Coordinators, Research Nurses, Research Assistants/Technicians, laboratory staff, pharmacy, infusion clinic, and MRI staff.
• Provide guidance, education, and mentorship to research staff, including training on protocols, safety measures, CTMS, SOPs, and regulatory requirements.
• Assist with recruitment and training of new research nursing staff and support staff.
• Act as a blinded interviewer when required.
• Communicate regularly with sponsor help desks to resolve technical issues with study systems or devices.
• Provide input on organizational improvements and support departmental goals.

Other Responsibilities

• Travel to national/international investigator meetings, conferences, and study‑related events as required.
• Act as backup coordinator for other studies when necessary.
• Perform other related duties to meet study timelines, participant safety, and research priorities.
  

Consequence of Error/Judgement
Errors in judgment or failure to follow regulatory requirements may:

• Compromise participant safety.
• Result in protocol deviations, regulatory non‑compliance, or suspension of research activities.
• Jeopardize funding, sponsor confidence, and future clinical trial opportunities.
• Negatively impact the reputation of the MS Clinical Trials Program.

Clinical mistakes may be life‑threatening; the Research Nurse Coordinator must accurately assess eligibility, monitor for side effects, and maintain up‑to‑date clinical skills.

Supervision Received
Works independently under broad direction from the Research Manager, MS Clinical Trials Director, and Principal Investigators. Receives guidance for complex clinical, regulatory, or operational issues.

Supervision Given
Provides guidance, education, and support to Research Coordinators, Research Nurses, Research Assistants/Technicians, students, contracted service providers, and clinical personnel involved in study conduct.

Minimum Qualifications
Registered Nurse with BCCNP plus 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 related to equity, diversity, and inclusion

Preferred Qualifications

• Registered Nurse with current BCCNM registration; BScN preferred.
• Experience in neurology, MS, neuroimmunology, or infusion therapy preferred.
• Clinical research experience and ICH‑GCP certification preferred.
• Experience with electronic data capture systems, CTMS, and research databases.
• Strong communication, organizational, leadership, and problem‑solving skills.
• Ability to work independently and collaboratively in a multidisciplinary environment.
• Ability to maintain accuracy, attention to detail, confidentiality, and professionalism.
• Current CPR certification.