Clinical Research Associate II (FSP)

About the Role

Syneos Health is a global life sciences services organization focused on helping customers move faster from drug development through commercialization. The clinical solutions function brings a strong development mindset, using deep therapeutic and operational expertise to better understand customer needs and shape effective solutions. In this Functional Service Provider role, you will work with a collaborative team to support clinical research programs and help deliver outcomes that matter for patients.

Why Join Syneos Health

• The company invests in employee growth through career progression, supportive line management, technical and therapeutic training, peer recognition, and rewards.
• An inclusive workplace culture is emphasized, with a focus on authenticity, belonging, and shared purpose.
• The organization is committed to improving healthcare outcomes by bringing together global expertise to accelerate patient progress.

Responsibilities

• Carry out site qualification, initiation, interim monitoring, site management, and close-out visits, either on-site or remotely, while ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice, and the study protocol.
• Use professional judgment to assess site performance, identify issues, recommend corrective actions, and escalate serious concerns promptly to the project team.
• Confirm that informed consent is properly obtained and documented, and protect subject confidentiality throughout the study.
• Review factors that may affect participant safety or data integrity, including protocol deviations, violations, and pharmacovigilance concerns.
• Follow the Clinical Monitoring/Site Management Plan to assess site processes, review source documents and medical records, verify CRF data, and resolve queries within required timelines.
• Support study data capture using available systems and ensure sites comply with electronic data capture requirements.
• Conduct investigational product reviews where needed, including inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and return processes.
• Review the Investigator Site File, reconcile it with the Trial Master File, and ensure essential documents are archived according to local rules.
• Document study activities through follow-up letters, trip reports, communication logs, and other required records.
• Support recruitment, retention, and awareness efforts, and maintain tracking systems for site observations, actions, and status updates.
• Manage assigned site-level tasks, budgets, timelines, and communications to help meet project goals and deadlines.
• Serve as the main site contact or work with central monitoring as needed, and ensure site teams are trained and compliant with requirements.
• Prepare for and attend investigator meetings, sponsor meetings, monitoring meetings, and project-specific training sessions.
• Support audit readiness at the site and project level and assist with audit preparation and follow-up actions.
• For real world late phase work, provide site support across the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local teams, train junior staff when requested, flag out-of-scope work, and propose potential sites based on local knowledge.

Requirements

• Bachelor’s degree or RN in a related discipline, or an equivalent mix of education, training, and experience.
• Working knowledge of Good Clinical Practice, ICH guidelines, and other relevant regulatory requirements.
• Strong computer literacy and the ability to learn and use new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Availability for regular travel of up to 75%.
• For some assignments, compliance with site access requirements may be necessary, including providing personal or medical information requested by a site.
• The role may require flexibility to adapt quickly to changing priorities and manage multiple site activities.

Additional Information

The listed duties are not complete and may be expanded or changed at the company’s discretion without advance notice. Equivalent education, experience, or skills may be accepted instead of the exact qualifications stated. Nothing in this description should be treated as an employment contract. The company also states that it complies with applicable equal employment laws and provides reasonable accommodations where appropriate for candidates or employees with disabilities.

Role Summary

This Clinical Monitoring / CRA position focuses on protecting the quality and integrity of clinical research through remote and on-site site oversight, data review, compliance checks, and risk-based monitoring. The role may involve guiding site teams, supporting process improvements, and contributing to the delivery of clinical studies within a professional, individual contributor capacity.