Clinical Research Associate- Wound Care Experience Required

Accountabilities 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 of the Clinical Trial Management System (CTMS), participate in internal and sponsor meetings, and manage competing priorities to deliver on project commitments.

Requirements

Education: Bachelor's degree in Biology, Life Sciences, or a related scientific field.

Wound care monitoring experience: At least 2 years of experience monitoring wound care clinical trials. This is a mandatory requirement for the role.

Clinical research knowledge: Strong understanding of clinical research practices, ICH GCP, applicable local regulations, and regulatory and ethical requirements.

Independent execution: Proven ability to autonomously manage clinical trial monitoring activities, prioritize responsibilities, and maintain high standards of quality and compliance.

Technical proficiency: Good computer skills, including experience with clinical trial management systems, clinical trial databases, and electronic data capture (EDC) platforms.

Communication and relationship management: Excellent communication and interpersonal skills, with the ability to build positive, productive relationships with sponsors, clinical sites, investigators, and project teams.

Language proficiency: English proficiency and a strong command of the local language, both written and spoken, in the country where monitoring activities are performed.

Organization and attention to detail: Strong organizational skills, meticulous documentation practices, and the ability to manage multiple responsibilities effectively in a fast-paced environment.

Analytical and problem-solving skills: Ability to analyze complex issues, resolve ambiguous challenges, negotiate solutions, and manage priorities and time effectively.

Leadership and collaboration: Strong meeting management and cross-functional teamwork skills, with the ability to mentor colleagues, provide constructive guidance, and promote consistency across monitoring teams.

Professionalism and adaptability: Self-motivated, trustworthy, disciplined, and able to manage stress while maintaining a professional, service-oriented approach.

Travel flexibility: Willingness and ability to travel for onsite monitoring visits and other study-related activities as needed.

Location eligibility: The original posting lists remote opportunities in Boston and across the Americas. Candidates based in Brazil should confirm country-specific hiring eligibility, local language requirements, and employment arrangements with the hiring team.

Benefits

Competitive salary: The original posting lists a salary range of $95,000–$120,000. The final offer depends on the applicable location-specific range, confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. The currency and applicability of this range to candidates based in Brazil should be confirmed.

Remote work options: The position is advertised as remote, with opportunities listed across the Americas. Eligibility for Brazil-based candidates should be verified.

Professional development: Opportunities to develop clinical research expertise and grow professionally within clinical research and 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 colleagues and engage with clinical research teams across different locations.

Collaborative work environment: Join a multidisciplinary, international team that values initiative, accountability, teamwork, and the exchange of ideas.

Purpose-driven impact: Contribute to healthcare and life sciences research with the potential to support improved standards of care and patient experiences.

Additional benefits: Specific details about health insurance, paid time off, retirement plans, equipment, and other location-specific benefits were not provided in the original posting and should be confirmed with the hiring team.

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