Clinical Research Associate- Wound Care

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Clinical Research Associate – Wound Care Experience Required based in Canada.

We are seeking an experienced Clinical Research Associate with a strong background in wound care clinical trials to support high-quality clinical research and ensure the successful execution of clinical studies. In this role, you will independently oversee clinical trial site monitoring activities, safeguard data integrity, and ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. You will work closely with sponsors, investigators, project managers, and cross-functional clinical teams to resolve site challenges, support recruitment, and maintain study timelines and quality standards.

Your responsibilities will span site qualification, initiation, interim, and close-out visits, as well as regulatory documentation, safety reporting, and audit preparation. You will also contribute to team development by mentoring colleagues, supporting onboarding, and promoting consistent monitoring practices. This opportunity offers the chance to contribute to meaningful healthcare research within a collaborative, international environment that values accountability, innovation, and professional growth.

• Clinical trial site monitoring:
  Independently conduct qualification, initiation, interim, and close-out visits, both remotely and onsite, ensuring visits are completed on schedule and documented appropriately.

• Monitoring reports and follow-up:
  Prepare accurate, timely monitoring reports detailing site issues, resolutions, actions taken, protocol deviations, study progress, and participant enrollment status.

• Data integrity and quality control:
  Review source documentation and verify case report form (CRF) data for accuracy, completeness, and consistency. Perform quality checks on documents collected for electronic and paper Trial Master Files (eTMF/TMF).

• Protocol and regulatory compliance:
  Ensure adherence to ICH GCP guidelines, applicable FDA regulations, local regulatory requirements, ethical standards, and sponsor‑specific standard operating procedures (SOPs).

• Site and sponsor relationship management:
  Maintain regular communication with investigators and site teams, respond to sponsor requests, address site questions, monitor recruitment progress, and proactively resolve operational challenges.

• Safety reporting and investigational product accountability:
  Facilitate adverse event reporting, reconcile serious adverse event (SAE) reports with source documents and CRFs, and ensure appropriate investigational product accountability.

• Regulatory documentation and audit readiness:
  Review site regulatory binders, assist with collecting ethics‑related documentation and negotiating site contracts, and support site audit preparation when required.

• Study planning and coordination:
  Contribute to study‑specific monitoring plans and training presentations, coordinate with cross‑functional departments, and collaborate with in‑house CRAs, clinical trial coordinators, and data management teams to resolve data discrepancies.

• Technical leadership and mentoring:
  Provide guidance and feedback to other Clinical Research Associates, participate in co‑monitoring and evaluation visits, support new‑hire training and onboarding, and encourage consistent monitoring practices across the team.

• Project and budget oversight:
  For standalone monitoring projects, manage study budgets and act as a key contact for the sponsor. Provide monthly billing information to the finance team as required.

• Systems and process improvement:
  Contribute to the development and maintenance…