Clinical Research Nurse, College of Medicine (Saskatoon)

Clinical Research Nurse, College of Medicine (Saskatoon)

04 Nov
|
University of Saskatchewan
|
Saskatoon

04 Nov

University of Saskatchewan

Saskatoon

Clinical Research Nurse, College of Medicine Primary Purpose: The Clinical Research Nurse’s (CRN) primary purpose is to proficiently assist the Principal Investigator (PI) and research team by providing research coordination and support.

Success in the role will require some judgment and decision making and following research regulations, as well as procedures and guidelines set by the PI and collaborating with the research team.

Nature of Work: The CRN reports to the Director of Research and is accountable to the Principal Investigator (PI).

The position is responsible for coordinating clinical studies within the PI's research program, encompassing both protocol-required nursing care and the operational and administrative aspects of assigned clinical trials.

This includes conducting clinical assessments and per-protocol procedures in accordance with nursing standards, the College of Registered Nurses of Saskatchewan (CRNS) standards, and the Regulated Health Professions Act, the position is responsible for coordinating all aspects of clinical trial delivery, including study start-up support, ongoing study management, regulatory compliance, participant coordination, and study close-out.

The role requires the ability to effectively navigate complex issues and concerns while managing moderate levels of stress associated with competing priorities and work pressures.

Excellent communication, organizational, analytical, and problem-solving skills are essential, as is the ability to work collaboratively as part of a multidisciplinary team.

The position may involve field work and irregular hours, including evening and weekend work.

Accountabilities: Provides effective and efficient services and support to clinical investigators.

Establishes and maintains strong working relationships with participants, researchers, and other study personnel.





Liaises between study sponsors, staff, investigators and the CTSU.

Ensures per protocol tasks are completed as per the schedule of assessments.

Maintains organization and proper documentation of research materials.

Ensures a safe setting for research participants and staff.

Duties: Study Set-Up Participates in site pre-qualification and qualification efforts.

Ensures all required approvals are in place prior to enrollment.

Study Execution/Oversight Recruits research participants and conducts eligibility assessment.

Coordinates per protocol procedures for study visits.

Performs per protocol study procedures including administering questionnaires and assessments.

Monitor study progress, recruitment targets, timelines, protocol compliance, and outstanding study requirements, escalating concerns or deviations as appropriate.

Administer study drug per protocol.

Performs venipuncture, phlebotomy, insertion of IV-lines.

Performs ECGs and vital signs collection and assessment.

Process study samples and store or distribute for analyses.

Creates and maintains accurate patient source documents ensuring GCP.

Resolves queries – Answer electronic data capture (eCRF/EDC) queries.

Maintains and completes accountability of sponsor-provided study supplies and devices.

Participates in Sponsor monitoring visits, audits and Health Canada inspections (communication with CRPs to renew approvals).

Assist with study budgets,



participant reimbursement, study-related expenses, and tracking of study activities in collaboration with the appropriate administrative and financial personnel.

Study Close-Out Prepares and submits case report forms in compliance with SOPs and regulations.

Verify data cleanliness for database lock.

Return, destroy or retain remaining supplies according to protocol.

Ship back sponsor-provided devices.

Organize the Investigator Site File/Regulator binder for proper archiving.

Research Administration Assists with monitoring and ordering of study specific supplies.

Attends meetings including investigator, site initiation/close out, and monitoring visits.

Provides 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 applicable nursing education program.

Experience in clinical research would be considered an asset.

Must be registered or eligible for registration with the Saskatchewan Registered Nurse’s Association.

Required Skills: Proficiency with Microsoft Office (Word, Excel, Outlook).

Excellent verbal and written communication skills.

Excellent organizational, time, and project management skills.

Excellent interpersonal and ability to collaborate with team members.

Detail oriented and able to exercise initiative and good judgement.

Training: The following certifications are required prior to commencing any study related procedures: TCPS2 Core Course Safety Orientation for Employees (USask) Off-Campus Activity Safety Plans (USask) Canada GCP (CITI) Clinical Research Coordinator (CITI) Health Canada Division 5 (CITI) Protocol Specific SOPs (N2) McMaster HiREB Chart Review Tutorial

📌 Clinical Research Nurse, College of Medicine (Saskatoon)
🏢 University of Saskatchewan
📍 Saskatoon

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