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 based in Canada . We are seeking a detail-oriented Clinical Research Associate with specialized experience in wound care clinical trials to support the successful execution and oversight of clinical research studies. In this role, you will independently manage site monitoring activities, safeguard data integrity, and ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. You will collaborate with sponsors, investigators, project managers, and cross-functional clinical teams to maintain study quality, address site challenges, and support effective trial delivery. Beyond monitoring, you will contribute to study planning, regulatory documentation, audit readiness, and patient recruitment oversight. You will also help strengthen team performance through mentoring, training, and consistent monitoring practices. This is an opportunity to contribute to meaningful clinical research in a collaborative, international, and innovation-driven environment, with remote work options and opportunities to engage with diverse stakeholders. Accountabilities - Clinical trial site monitoring: Conduct site qualification, initiation, interim, and close-out visits remotely and onsite, ensuring appropriate documentation, timely follow-up, and adherence to study protocols. - Monitoring reports and documentation: Prepare accurate and timely monitoring visit reports covering site issues, resolutions, corrective actions, protocol deviations, study progress, and enrollment status. - Data integrity and quality assurance: Review source documents and verify case report form (CRF) data to ensure accuracy, completeness, and consistency.

Perform quality control checks on documentation collected for electronic and paper Trial Master Files (eTMF/TMF). - Regulatory and protocol compliance: Ensure compliance with ICH GCP guidelines, applicable FDA requirements, local regulations, ethical standards, and sponsor-specific standard operating procedures (SOPs). - Site relationship management: Maintain regular communication with investigators and site staff, respond to questions, monitor patient recruitment and accrual rates, and proactively resolve site-related issues. - Safety reporting and investigational product oversight: Facilitate adverse event reporting, reconcile serious adverse event (SAE) reports against source documentation and CRFs, and ensure appropriate investigational product accountability. - Regulatory documentation and site readiness: Review site regulatory binders, support the collection of ethics documents, assist with site contract negotiations, and prepare study sites for audits when required. - Study planning and coordination: Contribute to study-specific monitoring plans and training materials, coordinate with cross-functional teams to resolve monitoring issues, and work with in-house CRAs, clinical trial coordinators, and data management teams to resolve data discrepancies. - Team leadership and mentoring: Provide guidance and feedback to other CRAs, support new-hire training and onboarding, participate in co-monitoring and evaluation visits, and promote consistency and collaboration across the team. - Project and budget management: For standalone monitoring projects, manage study budgets and serve as a key point of contact for sponsors. Provide monthly billing information to the finance team as required. - Systems and continuous improvement: Contribute to the development and maintenance of the Clinical Trial Management System (CTMS), participate in internal and sponsor meetings, and manage competing priorities to deliver commitments effectively. Requirements - Education: Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.