🧾 Job Title
CRA II / Sr CRA - Sponsor Dedicated - Oncology + General Medicine (Home-Based in Western US)
Updated: September 25, 2025
Location: USA – AZ – Remote
Job ID: 25102049
🏢 About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success.
We combine clinical, medical affairs, and commercial expertise to deliver innovative outcomes for modern healthcare challenges.
With 29,000 employees in 110 countries, we believe:
“Work Here Matters Everywhere.”
🌍 Why Work with Us
💡 Career Growth – Continuous career development, training, and advancement opportunities
🤝 Supportive Culture – Engaged line management and peer recognition programs
🧘 Total Self Culture – Be authentically yourself and thrive in an inclusive workplace
🌐 Diversity & Inclusion – Bringing diverse thoughts and perspectives together to foster belonging
🎯 Job Responsibilities
🔹 Monitoring & Compliance
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote)
Ensure ICH-GCP, GPP, and regulatory compliance
Evaluate site and staff performance; escalate serious issues and develop corrective action plans
🔹 Patient Safety & Data Integrity
Verify informed consent process and documentation
Protect patient confidentiality
Identify protocol deviations/violations and pharmacovigilance issues
🔹 Source Data & Documentation
Review source documents, CRFs, and medical records
Ensure accurate and complete data entry and timely query resolution
Manage electronic data capture (EDC) compliance
🔹 Investigational Product (IP) Oversight
Perform IP inventory, reconciliation, and storage review
Verify IP dispensing per protocol
Ensure labeling, import/export, and release/return compliance
🔹 Site File Management
Routinely review Investigator Site File (ISF) for accuracy
Reconcile ISF with Trial Master File (TMF)
Ensure archiving compliance
🔹 Documentation & Communication
Prepare confirmation/follow-up letters, trip reports, and communication logs
Track observations, status, and action items in project systems
Support patient recruitment, retention, and site engagement
🔹 Project Management
Understand project scope, budget, and timelines
Manage site-level deliverables and timely issue resolution
Act as primary liaison with site personnel and Central Monitoring Associates
🔹 Training & Audit Readiness
Ensure site training compliance
Participate in Investigator Meetings, Sponsor meetings, and staff training
Support audit readiness and follow-up actions
📘 Additional Responsibilities (for Real-World Late Phase Studies)
Support site lifecycle from identification to close-out
Conduct chart abstraction and data collection
Collaborate with Sponsor affiliates, MSLs, and local country staff
Train junior staff as needed
Suggest potential sites based on local treatment insights
🎓 Qualifications
Bachelor’s Degree or Registered Nurse (RN) in a related field
Strong knowledge of ICH-GCP and regulatory guidelines
Proficiency in computer systems and new technologies
Excellent communication, presentation, and interpersonal skills
Ability to travel up to 75% regularly
🩺 Note (US Only):
Some sites may require medical or personal information for facility access. Compliance is mandatory for continued employment.
💰 Compensation & Benefits
Competitive base salary (range varies by qualifications and region)
Health, Dental, and Vision insurance
401(k) with company match
Stock Purchase Plan eligibility
Bonus/Commission opportunities
Flexible Paid Time Off (PTO) and Sick Leave
Company Car or Car Allowance (where applicable)
🧠 Summary
Roles within Clinical Monitoring / CRA focus on:
Ensuring trial integrity via centralized and on-site monitoring
Using data analytics and risk-based monitoring
Collaborating with site teams to improve quality and compliance
Managing study delivery, data accuracy, and regulatory adherence
This is an individual contributor role requiring practical, hands-on experience and the ability to manage components of projects and processes.
🌐 About Syneos Health (Quick Facts)
Partnered in 94% of FDA Novel Drug Approvals
Involved in 95% of EMA Authorized Products
Conducted 200+ Studies across 73,000 sites
Supported 675,000+ Trial Patients
🔗 Learn More: syneoshealth.com
🤝 Equal Opportunity & Compliance
Syneos Health is committed to:
Equal Employment Opportunity (EEO)
Americans with Disabilities Act (ADA) accommodations
Inclusive hiring aligned with EU Equality Directives
📩 Application
Interested?
👉 [Apply Now]
or
💼 Join our Talent Network to stay updated on future opportunities.
💡 If your experience doesn’t align perfectly, apply anyway — transferable skills are valued.
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