Clinical Research Associate

Field Clinical Research Associate

This role supports the Clinical Operations team by overseeing clinical studies, ensuring high‑quality human study data collection, and facilitating collaboration between internal study teams, contract research organizations, and clinical sites. You will take ownership of site monitoring and study oversight for multiple clinical studies, primarily focusing on software and medical device projects rather than pharmaceuticals. The position requires a flexible, detail‑oriented professional who can thrive in a dynamic environment, manage multiple projects, and contribute to impactful research that supports cutting‑edge technology development.

• Assist with clinical study closure activities, including preparing and collecting close‑out documentation and organizing study files for long‑term storage.
• Monitor clinical sites for multiple clinical studies, ensuring compliance with study protocols, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate closely with contract research organizations and university sites to facilitate training of site and vendor personnel and support clinical trial execution.
• Track and maintain regulatory documentation and ensure that all required records are complete, accurate, and up to date.
• Work with incoming study data to reconcile data reports, identify discrepancies, and generate reports for invoicing and other operational needs.
• Resolve data queries and delinquencies in a timely manner, coordinating with internal teams and external sites as needed.
• Extract data from source documents for research studies as directed, ensuring accuracy and adherence to study requirements.
• Perform data tracking and ensure that the correct data files are loaded, organized, and available when and where needed.
• Track projects and study progress using spreadsheets and other tracking tools, maintaining clear and organized records.
• Navigate and support multiple concurrent projects, including studies approaching closure, ensuring that all data files are reviewed, checked, and approved by internal engineering teams.
• Confirm that data sets received from sites are complete, properly uploaded, and ready for submission, coordinating with internal cross‑functional teams.
• Facilitate communication among various stakeholders, including internal teams, field study teams, and external partners, to ensure aligned expectations and smooth study execution.
• Identify logistical and operational issues within clinical studies and propose practical solutions to maintain study timelines and quality.
• Contribute to projects involving health technologies and wearable medical devices, supporting technology development through robust clinical data collection.
• Act as a subject‑matter expert in clinical study oversight, taking the lead in setting up monitoring processes and collaboration frameworks based on prior experience.
• Participate in internal meetings (approximately 25% of the time) and work across cross‑functional teams to align on study status, data quality, and operational priorities.
• Manage own workflow, prioritize tasks, and meet tight deadlines without sacrificing quality or compliance.
• Formulate solutions independently by leveraging available resources and maintaining a proactive, self‑sufficient approach to daily operations.
• Be open to travel when required for site monitoring or study needs, while conducting most monitoring activities virtually.

• Minimum of 3 years of clinical study oversight experience, including hands‑on support for clinical operations.
• Experience collaborating with contract research organizations and clinical sites to support study execution.
• Experience facilitating training of site and vendor personnel for clinical trials.
• Proven track record in tracking and managing regulatory documentation for clinical studies.
• Experience in analyzing and reconciling clinical study data and generating operational or invoicing reports.
• Demonstrated ability to monitor clinical sites and ensure adherence to study protocols and regulatory standards.
• Strong attention to detail to ensure compliance with study protocols, accurate reporting, and appropriate…