Clinical Trials Research Nurse

Department: Clinical Research

Reports to: Clinical Research Programs Director and Principal Investigator(s)

Location: In-person at Initio Medical Group (Burnaby, BC)

Position type: Part-time (hours may vary based on study visit schedules)

Position Summary

Initio Medical Group provides diagnostic services, therapeutics, and clinical research. The Clinical Research Nurse (Clinical Trials Nurse Coordinator) is the primary on-site clinical operator for sponsored and investigator-initiated studies, ensuring safe, protocol-compliant delivery of study procedures and high-quality patient experience. This role is designed to minimize the time burden on the Principal Investigator by independently coordinating and executing delegated clinical and research activities across the study lifecycle (start-up, conduct, and close-out).

Current work includes imaging and radiopharmaceutical studies (e.g., Lutetium-based trials), with planned expansion to therapeutic trials across prostate cancer and other disease areas (including systemic therapies such as chemotherapy/biotherapy, where applicable).

Key Responsibilities

A. Clinical Trial Nursing \& Patient Care

· Perform protocol-required clinical procedures and assessments (e.g., vitals, symptom review, medication reconciliation, targeted physical assessments, ECG collection, phlebotomy, IV insertion).

· Administer study-related interventions as delegated and within scope (e.g., IV infusions/injections, supportive medications, hydration), including adherence to infusion standards and required certifications.

· Coordinate and prepare patients for imaging procedures and radiopharmaceutical visits; provide clear instructions, aftercare guidance, and education on precautions (including radiation safety instructions when applicable).

· Monitor participants during and after procedures for adverse events (AEs) and serious adverse events (SAEs); provide triage and timely escalation to the Principal Investigator per protocol and clinic policies.

· Document all study-related nursing activities in source documents and the clinic EMR (as applicable) with accuracy, timeliness, and confidentiality.

· Collect, process, label, and prepare biological specimens per protocol (including packaging/shipping when required) and maintain chain-of-custody documentation.

· Maintain study supplies and equipment readiness (e.g., temperature monitoring, calibration checks, inventory control) and support a safe clinical environment.

B. Clinical Trial Operations, Coordination \& Data

· Support participant screening, recruitment, and informed consent processes in accordance with protocol and delegated authority.

· Schedule and coordinate study visits within protocol windows; arrange required labs, imaging, and follow-up calls; track visit completion and retention milestones.

· Enter, review, and reconcile data in electronic data capture systems (EDC/eCRFs) and respond to data queries in collaboration with monitors and the study team.

· Maintain accurate and complete study documentation (e.g., source documents, visit worksheets, delegation logs, training logs, screening/enrollment logs).

· Support study monitoring visits, site initiation visits, audits/inspections, and close-out activities; ensure timely resolution of action items.

· Liaise with sponsors, Contract Research Organizations (CROs), Clinical Research Associates (CRAs), laboratories, imaging partners, and ethics boards as needed.

C. Regulatory \& Quality Compliance

· Ensure studies are conducted in compliance with ICH-GCP, Tri-Council Policy Statement (TCPS 2), Health Canada requirements (including Division 5, where applicable), and local Research Ethics Board (REB) approvals.

· Assist with REB submissions (initial, amendments, renewals), site documentation, and maintenance of regulatory binders and essential documents.

· Follow clinic SOPs and contribute to continuous improvement of research workflows (e.g., creating/updating nursing procedure checklists, visit flow sheets, and safety processes).

· Adhere to applicable safety regulations (including CNSC-related requirements for radiopharmaceutical studies) and occupational health policies.

D. Communication \& Team Support

· Serve as a key point of contact for participants, ensuring a professional, compassionate, and responsive experience throughout the study.

· Communicate proactively with the Principal Investigator and research leadership regarding participant status, safety concerns, scheduling constraints, and protocol deviations.

· Participate in research team meetings and contribute to feasibility assessments and operational planning for new trials.

· Support orientation/training of new research staff on study procedures and clinic workflows as needed.

Qualifications

· Registered Nurse (RN) in good standing with the British Columbia College of Nurses and Midwives (BCCNM).

· Minimum 2 years of recent clinical nursing experience; oncology, urology, infusion therapy, nuclear medicine, or ambulatory specialty clinic experience is an asset.

· Previous experience in clinical trials or clinical research coordination is strongly preferred.

· Competency in IV therapy, phlebotomy, ECG collection, and patient assessment/documentation.

· ACRP/SOCRA certification and/or Oncology Nursing certification is an asset

· Completion of, or willingness to complete, required research training: ICH-GCP, TCPS 2, and any sponsor- or protocol-specific training modules.

· For therapeutic trials involving systemic agents: chemotherapy/biotherapy administration certification (or willingness to obtain) may be required based on the study portfolio.

· Strong computer literacy and comfort with EMR systems and research platforms (e.g., EDC/eCRF systems, REDCap, CareConnect) and Microsoft Office (Word/Excel/Outlook).

· Excellent organizational skills, attention to detail, and ability to manage multiple concurrent studies and time-sensitive tasks.

· Professional, patient-centered communication style; ability to handle sensitive health information with discretion and confidentiality.

Preferred Assets

· Certification as a Certified Clinical Research Professional (CCRP) or equivalent, or demonstrated clinical research training.

· Experience with radiopharmaceutical studies and/or completion of radiation safety training relevant to the clinic environment.

· Familiarity with Health Canada submissions, REB processes, and clinical trial documentation (regulatory binders, drug accountability, deviation reporting).

· Experience with sample handling for clinical trials (processing, shipping, central lab coordination) and knowledge of relevant transport requirements.

Working Conditions

· This is a part-time, in-person position based at Initio Medical Group in Burnaby, BC (300-3185 Willingdon Green).

· Schedule flexibility may be required to accommodate study visits, imaging appointments, and sponsor timelines.

· May involve working with biological specimens, investigational products, and (for radiopharmaceutical studies) environments governed by additional safety procedures.

· Occasional travel between clinic and affiliated sites may be required depending on study needs.

Job Types: Part-time, Casual

Pay: $40.00-$60.00 per hour

Work Location: In person