Clinical Research Associate I (Remote – USA)
Syneos Health | Full-Time**
Location: USA (North Carolina – Remote)
Updated: December 4, 2025
Job ID: 25103725
Experience Required: 1–2 years of clinical trial experience or relevant medical/healthcare field experience
About the Role
Syneos Health is seeking a Clinical Research Associate I (CRA I) to support clinical trial operations across diverse therapeutic areas. This role is essential in ensuring regulatory compliance, data accuracy, patient safety, and site performance throughout the study lifecycle.
As a CRA I, you will conduct monitoring visits (on-site and remote), manage site-level quality, verify protocol adherence, and support efficient execution of clinical research activities. This position is ideal for professionals looking to advance their clinical operations career within a global biopharmaceutical organization.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, and close-out visits.
Ensure compliance with ICH-GCP, regulatory requirements, and study protocols.
Evaluate site performance and implement site-specific corrective actions when required.
Verify proper documentation of informed consent and ensure subject safety and confidentiality.
Data Verification & Quality Oversight
Perform Source Document Review and validate CRF data for accuracy and completeness.
Resolve data queries within defined timelines and support site teams with guidance.
Ensure compliance with electronic data capture (EDC) and other digital trial systems.
Investigational Product (IP) Management
Review IP accountability, storage, and dispensing procedures.
Ensure adherence to blinded/randomized study requirements and IP labelling standards.
Documentation & Reporting
Prepare monitoring visit reports, follow-up letters, communication logs, and audit-ready documentation.
Reconcile Investigator Site File (ISF) with Trial Master File (TMF).
Project Coordination
Support patient recruitment and retention strategies.
Manage site communication to ensure project timelines and deliverables are met.
Serve as primary liaison for assigned trial sites.
Real-World Evidence (RWE) / Late Phase Studies
(If assigned to RWE programs)
Conduct chart abstraction and data collection.
Collaborate with sponsor affiliates and local medical staff.
Ensure adherence to local regulations for late-phase study designs.
Qualifications & Experience Required
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field
(RN qualification or equivalent experience also accepted)
1–2 years of experience in clinical trials, healthcare, or medical field
Strong understanding of Good Clinical Practice (GCP) and regulatory requirements
Proficiency in computer applications and ability to adapt to new technologies
Excellent communication, presentation, and interpersonal skills
Ability to travel up to 75% for monitoring activities
Must comply with all site-specific credentialing and facility access requirements (USA)
Why Join Syneos Health
Comprehensive career development programs and technical training
Supportive leadership and global team collaboration
Competitive benefits package including:
Medical, Dental, Vision coverage
401(k) with company match
Employee Stock Purchase Plan
Performance-based bonuses
Car allowance (if applicable)
Flexible paid time off
Syneos Health fosters a Total Self Culture, promoting diversity, inclusion, and an environment where every employee feels valued.
About Syneos Health
With a presence across 110+ countries and collaboration on:
94% of all FDA-approved novel drugs in the past 5 years
95% of EMA-authorized products
Over 200 clinical studies, 73,000 sites, and 675,000+ trial participants
Syneos Health is a global leader in biopharmaceutical solutions, driving innovation and improving patient outcomes worldwide.
Apply Now
If you’re ready to contribute to impactful clinical research and advance your career in a global environment, submit your application today.
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