Oncology & General Medicine | Home-Based (Eastern United States)
Updated: December 22, 2025
Job ID: 25104670
Location: United States – Remote (Eastern US preferred)
Employment Type: Full-Time
Model: Sponsor-Dedicated | Clinical Operations
Syneos Health® is a globally leading, fully integrated biopharmaceutical solutions organization supporting the development and commercialization of innovative therapies. With a presence in over 110 countries and a workforce exceeding 29,000 professionals, Syneos Health partners with biopharmaceutical companies to deliver patient-focused, data-driven clinical research solutions.
Through its integrated Clinical Development model, Syneos Health places patients and sponsors at the center of every study, combining scientific expertise, operational excellence, and advanced technologies to accelerate drug development.
Syneos Health is seeking an experienced Clinical Research Associate II (CRA II) for a Sponsor-Dedicated role supporting Oncology and General Medicine clinical trials. This is a home-based position covering the Eastern United States, offering the opportunity to work closely with a single sponsor while maintaining consistent processes, systems, and therapeutic focus.
The CRA II will independently manage assigned investigative sites, ensure regulatory and protocol compliance, and play a key role in safeguarding subject safety and data quality throughout the clinical trial lifecycle.
Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site and remote) in accordance with ICH-GCP, GPP, protocol requirements, and applicable regulations.
Independently assess site performance, identify risks, and recommend corrective actions related to patient safety, protocol adherence, and data integrity.
Escalate critical issues promptly to project teams and contribute to effective issue resolution strategies.
Verify informed consent processes and ensure subject confidentiality and ethical conduct at all times.
Conduct source document verification (SDV) and ensure accuracy, completeness, and consistency of data entered into CRFs and EDC systems.
Drive timely query resolution and provide ongoing guidance to site staff to meet data cleaning and database lock timelines.
Review Investigator Site Files (ISF) and reconcile with the Trial Master File (TMF), ensuring regulatory inspection readiness.
Review investigational product (IP) storage, accountability, reconciliation, and dispensing processes.
Ensure IP is handled in compliance with protocol requirements, blinding/randomization procedures, and local regulatory standards.
Serve as the primary point of contact for assigned sites, ensuring investigators and site staff are trained and compliant.
Support subject recruitment, retention, and site engagement strategies for Oncology and General Medicine studies.
Participate in investigator meetings, sponsor meetings, internal monitoring calls, and study-specific training sessions.
Provide site- and project-level support for audit and inspection readiness activities.
Support real-world and late-phase studies when applicable, including chart abstraction and data collection.
Collaborate with sponsor affiliates, medical science liaisons, and local clinical teams.
Mentor junior CRA or site management staff as needed and proactively identify out-of-scope activities for escalation.
Bachelor’s degree in life sciences, nursing (RN), or a related discipline; equivalent education and experience will be considered.
Minimum 2–4 years of independent clinical monitoring experience within a CRO or sponsor environment.
Demonstrated experience supporting Oncology clinical trials; exposure to General Medicine studies is strongly preferred.
Solid working knowledge of ICH-GCP guidelines, FDA regulations, and global clinical research requirements.
Ability to independently manage multiple sites, priorities, and timelines in a sponsor-dedicated model.
Strong communication, presentation, documentation, and interpersonal skills.
High level of computer proficiency and adaptability to new clinical technologies and systems.
Willingness and ability to travel up to 75% within the Eastern US region.
US Requirement: Candidates must meet site-specific credentialing and medical documentation requirements to access clinical research facilities.
Syneos Health offers a competitive compensation and benefits package, including:
Salary Range: USD 70,100 – 126,100 per year (based on experience and 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 compliance with local regulations
Final compensation will be determined based on qualifications, experience, and business needs.
Support clinical programs contributing to 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Work in a stable, sponsor-dedicated model with consistent systems and therapeutic focus.
Gain exposure to complex Oncology studies while expanding General Medicine expertise.
Advance your CRA career within a globally respected CRO known for quality and innovation.
Apply through thepharmadaily.com to explore this CRA II – Sponsor Dedicated (Oncology & General Medicine) opportunity with Syneos Health.
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