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Nurse Specialist in Clinical Research Coordination
2 months ago
Core Objective: The primary objective of the Nurse Specialist in Clinical Research Coordination is to effectively support the Principal Investigator and the research team by providing comprehensive research management and assistance. Success in this role necessitates sound judgment, decision-making capabilities, and adherence to research regulations, alongside established procedures and guidelines set forth by the Principal Investigator while collaborating with the research team.
Scope of Responsibilities: The Nurse Specialist reports directly to the Director of Research and is accountable to the Principal Investigator. This position entails the coordination of clinical trials, which includes nursing and administrative responsibilities associated with the Principal Investigator's research initiatives. The Nurse Specialist will adhere to nursing standards in accordance with the College of Nurses and the Regulated Health Professionals Act when executing protocol-specific tasks. The ability to navigate complex issues and challenges with a moderate level of stress due to work demands is essential. Strong communication, organizational, analytical, and problem-solving skills are imperative. Team collaboration is a critical aspect of this role. The position may require fieldwork and non-standard hours, including evenings and weekends.
Key Responsibilities:
- Deliver effective and efficient support services to clinical investigators.
- Establish and nurture strong working relationships with participants, researchers, and other study personnel; act as a liaison between study sponsors, staff, investigators, and the Clinical Trial Support Unit.
- Ensure that protocol-specific tasks are completed according to the assessment schedule.
- Maintain organization and accurate documentation of research materials.
- Ensure a safe environment for both research participants and staff.
Specific Duties:
Study Preparation:
- Engage in site pre-qualification and qualification activities.
- Confirm that all necessary approvals are secured prior to participant enrollment.
- Recruit research participants and conduct eligibility evaluations.
Study Implementation:
- Coordinate protocol-specific procedures for study visits.
- Administer protocol-required study procedures, including questionnaires and assessments.
- Prepare, dispense, and administer study medications as per protocol.
- Perform venipuncture, phlebotomy, and IV line insertions.
- Conduct ECGs and collect vital signs for assessment.
- Process study samples and manage their storage or distribution for analysis.
- Create and maintain accurate patient source documents to ensure Good Clinical Practice (GCP).
- Participate in Health Canada inspections and sponsor audits.
Study Conclusion:
- Prepare and submit case report forms in compliance with Standard Operating Procedures (SOPs) and regulations.
Research Administration:
- Assist in monitoring and ordering study-specific supplies.
- Attend meetings, including investigator, site initiation/close-out, and monitoring visits.
- Provide orientation and training to research staff on relevant policies, procedures, standards, and regulations.
Qualifications:
Education and Experience: A Bachelor's degree in Nursing or completion of an accredited nursing education program. Experience in clinical research is advantageous. Must be registered or eligible for registration with the Saskatchewan Registered Nurse's Association.
Essential Skills:
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Exceptional verbal and written communication abilities.
- Strong organizational, time management, and project management skills.
- Excellent interpersonal skills with the ability to collaborate effectively with team members.
- Detail-oriented with the capacity to exercise initiative and sound judgment.
Required Training: The following certifications are mandatory prior to engaging in any study-related procedures:
- TCPS2 Core Course.
- Safety Orientation for Employees.
- Off-Campus Activity Safety Plans.
- Clinical Research Coordinator Certification.
- Protocol-Specific Standard Operating Procedures.
Department: Clinical Trial Support Unit
Status: Term position with potential for extension or transition to permanent.
Employment Group: Research Positions - Non-union.
Shift: Monday to Friday, 8:00 AM to 4:30 PM.
Full Time Equivalent (FTE): 1.0.
Salary: Salary range based on 1.0 FTE, starting salary commensurate with education and experience.
Number of Openings: 1.
Work Location: On Campus.
