Clinical Research Associate Service

Clinical Research Associate - Full-Service

Updated: Yesterday
Location: Morrisville, NC, United States
Job :-OTHLOC-1500-2

DCT-2DR

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. As a Clinical Research Associate – Full Service you will be responsible for managing site qualification, monitoring, management, and close‑out activities across the study lifecycle, ensuring compliance with ICH‑GCP, GPP and company SOPs. You will collaborate with investigators, study teams and sponsors to maintain study integrity and support clinical trial success.

• Perform site qualification, initiation, interim monitoring, management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and Good Pharmacoepidemiology Practice compliance.
• Verify informed consent processes and protect subject confidentiality; assess safety and data integrity issues at investigator sites.
• Follow the Clinical Monitoring/Site Management Plan to assess site processes, conduct source document review, verify CRF data accuracy, resolve queries and support electronic data capture requirements.
• Manage investigational product inventory and reconciliation, ensuring proper dispensation, storage and handling.
• Review the Investigator Site File for accuracy and completeness, and reconcile with the Trial Master File.
• Document activities via confirmation letters, follow‑up letters, trip reports and communication logs per SOPs; support recruitment, retention and awareness strategies.
• Manage project‑level site activities, budgets and timelines; act as primary liaison with site personnel and the Central Monitoring Associate.
• Attend Investigator Meetings and sponsor face‑to‑face meetings; participate in global monitoring and training sessions.
• Assist in audit readiness and support audit preparation and follow‑up actions.
• Maintain up‑to‑date knowledge of ICH‑GCP, regulations and SOPs; complete required training.
• Support study lifecycle activities, including study identification through close‑out and real‑world late‑phase study designs; train junior staff and identify out‑of‑scope activities.

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% of the time.
• U.S. only: compliance with Site access data requirements as part of employment.

This position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), employee stock purchase plan eligibility, commissions/bonus potential, and flexible paid time off. Eligibility for paid sick time may vary by location. Salary will vary based on qualifications, skills and proficiency.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants in performing the essential functions of the job.