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. Responsibilities 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. Essential Skills 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 follow‑up actions. Ability to identify logistical and operational issues within clinical studies and resolve them appropriately. Strong written and verbal communication skills, with experience facilitating communication among diverse stakeholders. Comfort working in a dynamic environment with frequent changes and tight deadlines. Proactive, self‑starter mindset with the ability to manage one’s own workflow and operate with minimal supervision. Experience working on clinical studies in the software or medical device industry, rather than in traditional pharmaceutical settings. Training and working knowledge of Good Clinical Practice (GCP) policies and guidelines. Familiarity with ICH guidelines relevant to clinical research. Willingness and ability to travel when required for study needs, while supporting primarily virtual monitoring activities. Additional Skills & Qualifications Experience similar to a clinical research coordinator, particularly in invoicing, data tracking, and trial close‑out activities. Experience working with or for a contract research organization or in a sponsor role supporting clinical studies. Experience in clinical operations, clinical trial execution, or field clinical roles such as Field Clinical Research Manager or Field Clinical Specialist. Exposure to health technologies and medical devices, especially wearable technology. Comfort working with spreadsheets and data tracking tools to manage project and study information. Experience navigating multiple concurrent projects and coordinating across cross‑functional teams. Ability to interact professionally with leadership and external partners, representing the clinical operations function effectively. Strong interpersonal skills and commitment to conducting impactful research in support of technology development. Why Work Here? You will contribute to innovative projects that help transform the health industry through wearable technology and advanced IT initiatives. The role offers regular interaction with organizational leadership, providing valuable learning opportunities and visibility for your work. You will have the chance to build strong relationships within the contract research and clinical research ecosystem, expanding your professional network. Your contributions will have a direct and meaningful impact on the success of multiple teams and projects while allowing you to grow your skills and shape clinical operations processes in a highly dynamic environment. Work Environment The work environment is dynamic and fast‑paced, with frequent changes that require flexibility and adaptability. You will manage multiple tasks and projects under tight deadlines while maintaining high standards of quality and compliance. Most monitoring activities occur virtually, with occasional travel to clinical sites when study needs require on‑site presence. You will be responsible for organizing your own workflow, taking initiative, and independently formulating solutions by leveraging available resources. The role involves regular collaboration with cross‑functional teams, engineering groups, and external partners, as well as consistent use of spreadsheets and digital tools for data tracking and project management. A proactive, self‑sufficient approach is essential to thrive in this environment. Job Type & Location Contract position based out of Sunnyvale, CA. Hybrid work arrangement. Pay & Benefits Hourly rate: $50.00 – $60.00/hr. Requirements Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Application Deadline This position is anticipated to close on Jun 19, 2026. Equal Opportunity The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. #J-18808-Ljbffr