Clinical Research Associate II (CRA II) – Sponsor Dedicated (Oncology & General Medicine) | Home-Based – Eastern US
Updated: December 22, 2025
Job ID: 25104670
Location: Remote – Eastern United States (USA)
Employment Type: Full-Time
Functional Area: Clinical Operations | Clinical Monitoring | Oncology Trials
Job Overview
Syneos Health, a global biopharmaceutical solutions organization, is hiring a Clinical Research Associate II (CRA II) for a Sponsor-Dedicated, Home-Based role supporting Oncology and General Medicine clinical trials across the Eastern United States.
This position is ideal for experienced CRAs seeking exposure to complex therapeutic areas, strong sponsor collaboration, and a flexible remote working model while maintaining high standards of clinical quality, compliance, and patient safety.
Key Responsibilities
Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, both on-site and remotely
Ensure full compliance with ICH-GCP, GPP, regulatory requirements, protocol guidelines, and SOPs
Evaluate site performance, identify risks, and proactively escalate critical issues to the project team with corrective action plans
Verify informed consent processes, subject confidentiality, patient safety, and clinical data integrity
Perform source document review (SDV) and verify accuracy and completeness of CRF and EDC data
Manage query resolution activities, ensuring timely closure in alignment with study timelines
Review and manage Investigational Product (IP) accountability, storage, reconciliation, and dispensing compliance
Maintain and reconcile Investigator Site Files (ISF) with the Trial Master File (TMF)
Document monitoring activities through trip reports, follow-up letters, communication logs, and tracking systems
Support subject recruitment, retention, and site engagement strategies
Act as the primary point of contact for assigned sites and collaborate closely with sponsor teams and central monitoring associates
Prepare for and participate in investigator meetings, sponsor meetings, audits, and inspections
Support audit readiness and follow-up actions at both site and project levels
Real-World / Late Phase Studies:
For real-world late phase studies, the role may operate under the title Site Management Associate II (SMA II), supporting site identification through close-out, chart abstraction, and data collection activities.
Required Experience and Qualifications
Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or a related discipline
Minimum 2–4 years of onsite and/or remote clinical monitoring experience as a CRA
Strong experience in Oncology clinical trials; General Medicine experience preferred
Demonstrated working knowledge of ICH-GCP guidelines, FDA regulations, and global clinical research standards
Proven experience with EDC systems, clinical trial documentation, and risk-based monitoring approaches
Excellent communication, documentation, and stakeholder management skills
Strong computer literacy and ability to adopt new clinical technologies
Ability to travel up to 75%, as required
Work Authorization & Compliance (US Only)
Candidates must be eligible to work in the United States
Employment may require providing medical or personal information for site access
Failure to meet site-specific access requirements may impact ongoing employment
Compensation & Benefits
Salary Range:
USD $70,100 – $126,100 annually (base salary)
Actual compensation will depend on experience, skills, therapeutic expertise, and geographic location.
Benefits may include:
Medical, Dental, and Vision insurance
401(k) with company match
Company car or car allowance
Employee Stock Purchase Plan (ESPP)
Performance-based bonus eligibility
Flexible paid time off (PTO) and sick leave (per local regulations)
Why Join Syneos Health
Work with a company involved in 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years
Exposure to global studies across 73,000+ sites and 675,000+ trial patients
Strong focus on career development, therapeutic training, and internal progression
Inclusive, people-first culture supporting diversity, collaboration, and innovation
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to diversity, inclusion, and accessibility. Reasonable accommodations are provided in accordance with the Americans with Disabilities Act (ADA) and applicable laws. Candidates with transferable skills are encouraged to apply.
Keywords for SEO & AI Search Optimization
Clinical Research Associate II jobs, CRA II Oncology jobs, Sponsor Dedicated CRA roles, Remote CRA jobs USA, Oncology clinical trials jobs, Home-based CRA Eastern US, Clinical Monitoring careers, Syneos Health CRA vacancies
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