🧾 Job Title
CRA II / Sr CRA – Sponsor Dedicated (Oncology + General Medicine)
📍 Location: USA – CA – Remote
🗓 Updated: September 25, 2025
🆔 Job ID: 25102049
🏢 About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success.
We transform clinical, medical affairs, and commercial insights into outcomes that address modern healthcare challenges.
Our Clinical Development Model places patients and customers at the center, ensuring innovation, agility, and speed in delivering therapies that change lives.
With 29,000 employees across 110 countries, Syneos Health offers a collaborative and inclusive environment where:
“Work Here Matters Everywhere.”
🌟 Why Work with Us
🚀 Career Development: Continuous learning, progression, and technical/therapeutic training
💬 Supportive Leadership: Engaged line managers and peer recognition programs
🧘 Total Self Culture: Encouraging authenticity, diversity, and inclusion
🌍 Global Belonging: Diversity of thoughts, cultures, and perspectives makes everyone feel valued
We’re building the company we all want to work for — and one that our customers want to work with.
🎯 Job Responsibilities
🔹 Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote)
Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), regulations, and protocols
Evaluate site/staff performance and escalate issues with action plans
Maintain deep working knowledge of ICH/GCP Guidelines, regulatory requirements, and SOPs
🔹 Subject Safety & Data Integrity
Verify informed consent process and documentation for each subject
Protect patient confidentiality and ensure ethical compliance
Identify and assess protocol deviations, violations, and pharmacovigilance issues
🔹 Source Documentation & Data Review
Conduct Source Document Review (SDR) of site documents and medical records
Verify accuracy and completeness of data in Case Report Forms (CRFs)
Drive query resolution (on-site and remotely)
Ensure compliance with electronic data capture (EDC) requirements
🔹 Investigational Product (IP) Oversight
Perform IP inventory, reconciliation, and storage/security review
Verify IP dispensing and administration per protocol
Ensure compliance with labeling, import/export, and return/release processes
🔹 Documentation & Communication
Prepare and maintain confirmation/follow-up letters, trip reports, and communication logs
Track all observations, status, and action items in project systems
Support subject recruitment, retention, and site engagement
🔹 Project & Site Leadership
Understand project scope, budgets, and timelines
Manage site-level activities and deliverables
Serve as primary liaison with site personnel or collaborate with Central Monitoring Associates
🔹 Training, Meetings & Audit Readiness
Train and ensure compliance of all site/project team members
Attend Investigator Meetings, Sponsor meetings, and training sessions
Support audit readiness and follow-up on findings
📘 Additional Responsibilities (Real World Late Phase Studies)
Support site lifecycle from identification to close-out
Conduct chart abstraction and data collection
Collaborate with Sponsor affiliates, Medical Science Liaisons (MSLs), and local staff
Train junior staff, as requested
Identify potential sites using local treatment insights and HCP networks
Report out-of-scope activities to Lead CRA/Project Manager
🎓 Qualifications
🎓 Bachelor’s degree or Registered Nurse (RN) in a related field (or equivalent experience)
📘 Strong understanding of GCP/ICH Guidelines and applicable regulations
💻 Proficient in computer systems and adaptable to new technologies
🗣 Excellent communication, presentation, and interpersonal skills
✈️ Willingness to travel up to 75% regularly
🩺 US-Only Note:
Certain sites may require medical/personal information for facility access. Compliance is mandatory for continued employment.
💰 Compensation & Benefits
Syneos Health provides a comprehensive total rewards package, including:
🚗 Company car or car allowance (where applicable)
🏥 Health benefits: Medical, Dental, Vision
💰 401(k) with company match
📈 Employee Stock Purchase Plan eligibility
🎯 Bonus/Commission opportunities based on performance
🕒 Flexible PTO & Sick Leave (compliant with federal/state regulations)
💵 Salary Range:
Base pay varies depending on skills, experience, and qualifications
🧠 Role Summary
Roles within Clinical Monitoring / CRA are responsible for:
Overseeing and ensuring integrity of clinical research studies
Conducting remote and on-site monitoring to verify regulatory and protocol compliance
Using data analytics and risk-based monitoring to identify issues
Collaborating with site teams to enhance quality, compliance, and process efficiency
This is an individual contributor role that may also direct or mentor junior professionals, contributing to project design, implementation, and delivery.
🌐 About Syneos Health (Quick Facts)
Worked with 94% of all FDA Novel Drug Approvals in past 5 years
Partnered in 95% of EMA Authorized Products
Conducted 200+ studies across 73,000 sites
Supported over 675,000 trial patients globally
🔗 Learn more: www.syneoshealth.com
⚖️ Equal Opportunity & Compliance
Syneos Health is committed to:
🤝 Equal Employment Opportunity (EEO)
💼 ADA Accommodations for applicants/employees
🌍 Diversity, Inclusion, and EU Equality Directive compliance
📩 How to Apply
✅ Apply Now
or
💼 Join Our Talent Network to stay updated on future opportunities.
💡 Even if your experience isn’t a perfect match, we encourage you to apply — we value transferable skills and diverse perspectives.
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Zaventem |South America :
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Auckland |New Zealand :
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