FSP- CRA II/ SCRA Clinical Research Associate

About Syneos Health

Syneos Health is a premier, fully-integrated life sciences services company dedicated to accelerating customer success across the drug development and commercialization continuum. Our Clinical Solutions team leverages extensive expertise and a drug development perspective to understand and fulfill customer requirements, functioning within Functional Service Provider or Full-Service setups. We are a collaborative, driven, and agile team intent on making a meaningful impact on healthcare.

Key Job Responsibilities

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice; evaluate site and staff performance and escalate critical issues promptly; formulate site-specific action plans.
• Confirm adequate informed consent processes and documentation for each participant; ensure confidentiality and evaluate factors impacting patient safety and data integrity at investigator sites.
• Review source documents and medical records per monitoring plans; verify accuracy and completeness of clinical data entered in case report forms; manage query resolution both remotely and onsite within timelines; ensure adherence to electronic data capture protocols.
• Manage investigational product inventory, reconciliation, storage, and security; verify correct dispensing and administration according to protocol; ensure proper labeling, importation, and return in compliance with GCP and local regulations.
• Assess and maintain accuracy and completeness of Investigator Site File and reconcile with Trial Master File; ensure compliant archiving of essential documents.
• Document monitoring activities in required project records; support subject recruitment, retention, and awareness strategies; track observations and action items to resolution.
• Understand project scope, budgets, and timelines; coordinate site-level activities and communications to meet project objectives and adapt swiftly to changing priorities.
• Serve as a primary contact for site personnel or collaborate with Central Monitoring Associates; ensure team training and compliance with applicable requirements.
• Prepare for and participate in Investigator and sponsor meetings; attend global clinical monitoring and project meetings as required; engage in clinical training sessions.
• Provide audit readiness guidance at site and project levels; support audit preparations and follow-up actions.
• Maintain updated knowledge of relevant guidelines, regulations, and company SOPs; fulfill required training assignments.
• For Real World Late Phase studies, support site activities throughout study lifecycle including identification, chart abstraction, and data collection; collaborate with sponsors and local staff; train junior staff as needed; identify out-of-scope activities and suggest potential sites based on local treatment patterns and healthcare networks.

Minimum Qualifications

• Bachelor’s degree or Registered Nurse qualification in a relevant field or equivalent education and experience.
• Familiarity with Good Clinical Practice/ICH Guidelines and applicable regulatory frameworks.
• Proficient computer skills and adaptability to new technologies.
• Excellent communication, presentation, and interpersonal abilities.
• Willingness and capability to travel up to 75% regularly.
• US-based employees may need to provide personal information to gain access to certain sites, with compliance mandatory for continued employment.

Additional Information

Responsibilities outlined are not exhaustive. Syneos Health may assign other duties at its discretion. Qualifications may be substituted with equivalent experience or skills. This description does not constitute an employment contract. The company is committed to compliance with discrimination laws and providing reasonable accommodations per applicable regulations.

Company Impact

Syneos Health has contributed to 94% of all novel FDA-approved drugs in the last five years, supported 95% of EMA authorized products, conducted over 200 studies across 73,000 sites, involving more than 675,000 trial patients globally.