Clinical Research Associate - Full-Service

Syneos Health, Inc.; Morrisville (NC); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health benefits

Company car or car allowance

401(k) company match

Employee stock purchase plan eligibility

Flexible paid time off

Job summary

Syneos Health, Inc. is seeking a Clinical Research Associate in Morrisville, NC. In this role, you will manage site qualification, monitoring activities, and ensure compliance throughout the study lifecycle. You will collaborate with investigators and study teams to ensure clinical trial success.

This position offers a comprehensive benefits package, including health benefits, a company car or car allowance, and flexible paid time off. You should expect to travel up to 75% of the time.

Qualifications

• 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 regulatory requirements.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.

Responsibilities

• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Verify informed consent processes and protect subject confidentiality.
• Manage investigational product inventory and reconciliation.
• Document activities via confirmation letters and communication logs.

Skills

Knowledge of Good Clinical Practice/ICH Guidelines

Strong computer skills

Excellent communication skills

Ability to travel up to 75% of the time

Education

Bachelor’s degree or RN in a related field

Job description

Clinical Research Associate - Full-Service

Updated: Yesterday
Location: Morrisville, NC, United States
Job ID:25109785-OTHLOC-1500-2DCT-2DR

Description

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.

Job Responsibilities

• 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.

Qualifications

• 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.

Benefits and Compensation

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.

Equal Opportunity Employer

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.