Clinical Research Associate- Wound Care

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. Wound care experience: At least 2 years of experience monitoring wound care clinical trials; this is a required qualification. Clinical research expertise: Strong knowledge of clinical research practices, ICH GCP, local regulatory requirements, and applicable regulatory and ethical standards. Independent monitoring capabilities: Demonstrated ability to manage clinical trial monitoring activities autonomously, prioritize tasks, and ensure quality and compliance throughout the study lifecycle. Technical proficiency: Good computer skills and experience using clinical trial management systems, clinical trial databases, and electronic data capture (EDC) platforms. Communication and relationship management: Excellent written and verbal communication skills, with the ability to establish and maintain positive working relationships with sponsors, clinical sites, investigators, and project team members. Language proficiency: Strong command of the local language, both written and spoken, in the country where monitoring activities are performed. English is also listed as a required language. Organization and analytical skills: Strong attention to detail, organizational skills, and the ability to manage multiple tasks in a fast-paced environment while maintaining high standards of accuracy. Problem-solving and leadership: Strong analytical, negotiation, meeting management, and cross-functional collaboration skills, along with the ability to resolve complex or ambiguous challenges and provide effective guidance to colleagues. Professional approach: Self-motivated, trustworthy, disciplined, adaptable, and comfortable working in a collaborative environment with evolving priorities. Travel flexibility: Willingness and ability to travel as needed for onsite monitoring visits and other study-related activities. Work location eligibility: The original posting lists remote opportunities in the Americas, including Boston. Candidates based in Brazil should confirm country-specific hiring eligibility and local employment arrangements during the application process. Benefits Remote work options: The role is advertised as remote, with locations listed across the Americas. Availability for candidates based in Brazil should be confirmed. Competitive salary range: The original posting lists an annual salary range of $90,000–$130,000. The final offer depends on the applicable location-specific range, confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. The range and currency applicability for Brazil should be verified with the hiring team. Professional development: Opportunities to develop expertise and advance professionally within clinical research and clinical development. Flexible work programs: Flexible work arrangements are highlighted as part of the broader employee offering, subject to role and location eligibility. Global collaboration and travel: Opportunities to work with international teams and engage with colleagues and stakeholders across different markets. Creative and collaborative culture: An environment that encourages initiative, teamwork, entrepreneurial thinking, and the exchange of ideas. Purpose-driven work: The opportunity to contribute to healthcare and life sciences research with the potential to support improved patient care and outcomes. Additional benefits: Specific details regarding healthcare coverage, paid time off, retirement plans, equipment, and other location-specific perks were not provided in the original posting and should be confirmed with the hiring team.