Senior Clinical Research Associate II – Sponsor Dedicated (Oncology)
Location: Home-Based – Northeast USA (Remote)
Job Type: Full-time, Remote
Job ID: 25101844
Updated: September 15, 2025
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We deliver innovative clinical, medical affairs, and commercial insights to improve patient outcomes. Our teams operate in Functional Service Provider (FSP) partnerships and Full-Service environments, collaborating to streamline clinical development and deliver therapies faster.
Why Join Syneos Health:
Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic training
Peer recognition and total rewards programs
Total Self culture promoting authenticity, diversity, and inclusion
Role Overview
The Sr. CRA II is responsible for monitoring oncology clinical trials and ensuring compliance with ICH-GCP, protocols, SOPs, and regulatory requirements. This role combines individual contributor responsibilities with functional oversight, including mentoring junior CRAs and acting as a primary liaison with study sites.
Core Responsibilities:
Conduct on-site and remote monitoring of clinical research studies
Verify data accuracy, completeness, and adherence to study protocols
Develop monitoring tools, processes, templates, and checklists
Contribute to study design, protocol development, and methodology input
Manage and direct lower-level professionals or processes
Maintain accurate and timely documentation of site visits, monitoring activities, and reports
Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs)
Identify and resolve clinical trial issues impacting conduct or data integrity
Provide training, mentorship, and guidance to junior CRAs
Ensure audit readiness at site and project level
Detailed Responsibilities
Ensure regulatory, ICH-GCP, and protocol compliance across site qualification, initiation, interim monitoring, management, and close-out
Evaluate site and staff performance; recommend site-specific actions and escalate serious issues
Verify informed consent process and assess factors affecting patient safety and data integrity
Conduct Source Document Review, data verification, and query resolution
Ensure compliance with electronic data capture, investigational product inventory, storage, and security
Review Investigator Site File (ISF) and reconcile with Trial Master File (TMF)
Document site activities through trip reports, confirmation/follow-up letters, and communication logs
Act as primary site liaison and provide guidance on training and audit readiness
Qualifications
Education:
Bachelor’s degree in a related field
Experience:
Minimum 6 years of independent clinical monitoring experience (oncology preferred)
3–5 years in clinical research or related field required
Experience supervising or mentoring junior CRAs preferred
Skills & Knowledge:
Strong knowledge of clinical trial processes and regulations
Proficiency in clinical trial management systems and software
Excellent organizational, analytical, and problem-solving skills
Strong communication and interpersonal skills
Ability to manage multiple projects and priorities independently
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Certifications:
Certified Clinical Research Professional (CCRP) or equivalent preferred
Compensation & Benefits
Salary Range: $80,600 – $145,000 (dependent on qualifications, experience, location)
Benefits may include:
Company car or car allowance
Health benefits (Medical, Dental, Vision)
Company match 401(k)
Employee Stock Purchase Plan eligibility
Commissions/bonus based on performance
Flexible paid time off (PTO) and sick time
Impact & Contribution
Ensure clinical trials are conducted, recorded, and reported per protocol and regulatory standards
Contribute to the quality and integrity of clinical data
Protect confidentiality and safety of trial participants
Act as functional lead at site and project levels
Provide guidance and recommendations to sites and project teams
Additional Information
Tasks may evolve based on company discretion
Transferrable skills considered for applicants with relevant experience
Compliance with Americans with Disabilities Act and reasonable accommodations
Learn more: Syneos Health
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