Clinical Research Associate II – Sponsor Dedicated | Oncology & General Medicine | Home-Based (Eastern US)
Location: USA – Remote (Eastern US)
Job Type: Full-Time
Job ID: 25104670
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development, medical affairs, and commercial strategies. We place the patient and customer at the center of every solution, ensuring the delivery of high-quality therapies while driving operational excellence.
With 29,000 employees across 110 countries, we provide a growth-oriented environment, career progression, and a culture built on diversity, inclusion, and professional development.
Role Overview
We are seeking a CRA II – Sponsor Dedicated to manage and monitor oncology and general medicine clinical trials. This home-based role requires oversight of study sites throughout the study lifecycle, including site initiation, monitoring, and close-out, ensuring compliance with ICH-GCP, regulatory standards, and sponsor-specific protocols.
The ideal candidate combines clinical trial expertise, strong site management skills, and effective communication to drive study success while maintaining patient safety and data integrity.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Evaluate site performance, staff competency, and protocol adherence; escalate critical issues and recommend corrective actions.
Ensure proper informed consent documentation and protection of patient confidentiality.
Perform source document verification, CRF review, and query resolution to maintain accurate, complete, and compliant clinical data.
Support investigational product (IP) accountability, including inventory management, dispensing, administration, and storage compliance.
Reconcile Investigator Site Files (ISF) with the Trial Master File (TMF) and ensure archiving of essential documents per local regulations.
Project & Communication Management
Document monitoring activities through trip reports, follow-ups, and communication logs.
Track site performance, recruitment, and retention metrics.
Collaborate with study site staff, sponsor affiliates, medical science liaisons, and cross-functional teams.
Provide training and guidance to junior staff as needed and act as a primary liaison for site-level issues.
Support audit readiness and follow-up actions to ensure regulatory and sponsor compliance.
Regulatory Compliance & Quality Assurance
Maintain working knowledge of ICH/GCP, local regulations, and company SOPs.
Apply risk-based monitoring techniques and data analytics to identify trends, deviations, and potential safety or quality issues.
Ensure site compliance with electronic data capture and clinical trial standards.
Required Qualifications
Education & Experience:
Bachelor’s degree or RN in a relevant field; equivalent combination of education and experience considered.
Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
Demonstrated ability to manage study sites remotely and on-site in a home-based environment.
Skills & Competencies:
Excellent communication, presentation, and interpersonal skills.
Strong organizational, analytical, and problem-solving capabilities.
Ability to manage multiple sites, projects, and priorities effectively.
Willingness and ability to travel up to 75% regularly.
Why Join Syneos Health
Work remotely while managing sponsor-dedicated oncology and general medicine trials.
Gain experience in risk-based monitoring, data analytics, and clinical trial oversight.
Collaborate with global project teams, enhancing your professional growth.
Enjoy comprehensive benefits, including health coverage, 401k matching, stock purchase plans, flexible PTO, and performance-based incentives.
Apply Now
Advance your career as a CRA II – Sponsor Dedicated with Syneos Health, contributing to high-quality clinical research, patient safety, and successful trial outcomes across oncology and general medicine studies.
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Frank Scottile Blvd |Missouri :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
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