Clinical Research Support

Position Summary:

We are seeking a qualified and licensed Registered Nurse (RN) or Pharmacist to support our clinical research program through the safe and compliant execution of subcutaneous injections and investigational product handling. The successful candidate will play a key role in ensuring protocol adherence, participant safety, and high-quality data collection throughout all phases of clinical trials. This role will function under the oversight of the Investigator and Research Management, in accordance with Good Clinical Practice (GCP), SOPs, and Health Canada regulations.

Key Responsibilities:

Clinical & Medication Administration

• Perform subcutaneous injections of investigational products, in accordance with Ontario regulations and site delegation logs
• Conduct nursing/pharmacy duties as required by protocol, including:
  • Vital signs, ECGs, sample collection and processing, IV placement (if applicable)
  • Medication preparation, labeling, dispensing, and accountability
  • Management of emergency events per training and provider orders

Protocol Execution & Study Conduct

• Conduct study procedures as delegated by the Investigator, including participant screening, enrollment, and study visit completion
• Ensure proper informed consent is obtained and maintained
• Ensure study visits are scheduled and executed per protocol
• Follow clinical trial protocols, SOPs, and regulatory requirements for data and documentation integrity

Investigational Product & Supply Management

• Accurately document receipt, storage, dispensing, and destruction of investigational products
• Maintain temperature logs and storage security (ambient, refrigerated, or frozen)
• Ensure up-to-date drug accountability logs and patient administration records
• Assist with preparation of investigational medications under physician/pharmacist guidance

Safety & Compliance

• Monitor and report adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and REB/Sponsor requirements
• Support ongoing source data review, CRF/EDC completion, and resolution of queries
• Prepare for monitoring visits, audits, and inspections
• Perform quality control (QC) checks on documentation and processes

Collaboration & Training

• Maintain professional relationships with Investigators, participants, and sponsors
• Collaborate with site teams and external stakeholders to ensure smooth study execution
• Provide support and training to site staff as needed
• Attend investigator meetings, site trainings, and sponsor calls

Administrative Support

• Maintain ISF and regulatory documents
• Archive study materials post-closeout
• Support recruitment efforts and outreach events as needed
• Participate in on-call or rotating coverage schedules if applicable

Qualifications:

• Must be a Registered Nurse (RN) or Pharmacist licensed and in good standing in the Province of Ontario
• Qualified to administer subcutaneous injections under Ontario regulations
• Clinical research experience preferred (GCP, ICH guidelines)
• Strong organizational and communication skills