Clinical Research Associate II / Senior Clinical Research Associate
Full Service | Home-Based (Central United States)
Updated: December 23, 2025
Job ID: 25102606
Location: United States – Remote (Central US preference)
Employment Type: Full-Time
Functional Area: Clinical Monitoring / Clinical Operations
Company Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success across clinical development, medical affairs, and commercial strategies. With more than 29,000 professionals operating across 110 countries, Syneos Health partners with sponsors to deliver patient-centric clinical research solutions that address evolving regulatory and market needs.
Driven by a streamlined Clinical Development model, Syneos Health combines operational excellence, innovation, and scientific expertise to bring life-changing therapies to patients worldwide.
Role Overview
Syneos Health is hiring Clinical Research Associate II (CRA II) and Senior Clinical Research Associates (Sr CRA) to support full-service clinical trials in a home-based role covering the Central United States. This position plays a critical role in ensuring clinical trial quality, regulatory compliance, patient safety, and data integrity across all phases of study execution.
The CRA II / Sr CRA will independently manage assigned investigative sites, perform on-site and remote monitoring activities, and serve as a key liaison between investigators, sponsors, and project teams.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site and remote) in compliance with ICH-GCP, GPP, protocol requirements, and applicable regulations.
Evaluate investigator site performance and proactively identify risks related to subject safety, data integrity, protocol deviations, and pharmacovigilance concerns.
Escalate critical issues promptly and collaborate with project teams to develop and execute corrective and preventive action plans.
Data Quality & Compliance Oversight
Verify informed consent processes and ensure subject confidentiality and ethical conduct at all times.
Perform source document verification (SDV) and ensure accuracy, completeness, and timeliness of data entered into CRFs and EDC systems.
Drive timely query resolution and provide ongoing guidance to site staff to meet data quality timelines.
Review Investigator Site Files (ISF) and reconcile with the Trial Master File (TMF), ensuring proper documentation and archiving per regulatory requirements.
Investigational Product & Study Conduct
Oversee investigational product (IP) storage, accountability, reconciliation, and dispensing in accordance with protocol, GCP, and local regulations.
Assess risks related to blinding, randomization, labeling, import/export, and IP returns.
Project & Stakeholder Collaboration
Act as the primary site contact for assigned studies, ensuring site staff are trained and compliant with study-specific requirements.
Support patient recruitment, retention, and site engagement strategies.
Participate in investigator meetings, sponsor meetings, internal monitoring calls, and required clinical training sessions.
Support audit and inspection readiness and assist with follow-up activities as required.
Additional Responsibilities (CRA II / Real World Late Phase)
Support site management activities throughout the full study lifecycle, including site identification through close-out.
Perform chart abstraction and data collection activities for late-phase and real-world evidence studies.
Collaborate with sponsor affiliates, medical science liaisons, and local country teams.
Mentor junior staff when required and identify out-of-scope activities for escalation to Lead CRA or Project Manager.
Required Qualifications & Experience
Bachelor’s degree in life sciences, nursing (RN), or a related discipline; equivalent education and experience will be considered.
CRA II: Minimum 2–4 years of independent clinical monitoring experience within a CRO or sponsor environment.
Senior CRA: Minimum 4–6+ years of independent, full-cycle clinical monitoring experience, including site initiation through close-out.
Strong working knowledge of ICH-GCP guidelines, FDA regulations, and global clinical trial requirements.
Proven ability to manage multiple sites, priorities, and timelines in a fast-paced, matrix environment.
Excellent written, verbal, presentation, and interpersonal communication skills.
Strong computer literacy and ability to adopt new clinical systems and technologies.
Willingness and ability to travel up to 75% within the assigned region.
US Requirement: Candidates must comply with site-specific medical and credentialing requirements necessary to gain facility access as a condition of employment.
Compensation & Benefits
Syneos Health offers a competitive compensation and benefits package, which may include:
Base salary aligned with experience and geographic location
Medical, dental, and vision insurance
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based bonus opportunities
Company car or car allowance (role dependent)
Flexible paid time off (PTO) and sick leave in accordance with local regulations
Final compensation will be determined based on qualifications, experience, competencies, and business needs.
Why Join Syneos Health
Contribute to studies supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.
Work in a globally inclusive, people-focused organization with strong career development pathways.
Gain exposure to diverse therapeutic areas, innovative trial designs, and global sponsor partnerships.
Be part of a high-performance clinical monitoring team driving quality and patient safety.
Apply Now
Apply through thepharmadaily.com to explore this Clinical Research Associate II / Senior CRA – Home-Based (Central US) opportunity with a global biopharmaceutical leader.
Not ready to apply? Join the Talent Network to stay informed about upcoming CRA, Clinical Operations, and Monitoring roles worldwide.
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