Clinical Research Associate Ii / Sr Cra - Full Service - Onc + Gen Med (Home-Based In Western Us)

2-4 years

Not Disclosed

Remote

10 Oct. 2, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧠 Position: Clinical Research Associate II / Sr CRA (Full Service – ONC + Gen Med)

📍 Location: USA-OR-Remote (Home-Based in Western US)
🗓️ Updated: September 25, 2025
🆔 Job ID: 25101606

🌍 About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success.
We transform clinical, medical affairs, and commercial insights into meaningful outcomes to meet the demands of modern healthcare.

Our Clinical Development model places both the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline operations—to make Syneos Health not only easier to work with, but also easier to work for.

With 29,000 employees across 110 countries, Syneos Health is driven by the belief that:

WORK HERE MATTERS EVERYWHERE.

💡 Why Syneos Health

🚀 Career Growth: Focused on continuous learning, development, and progression.
🤝 Supportive Management: Engaged leaders committed to mentorship and guidance.
🧠 Training Excellence: Technical, therapeutic, and soft-skills training provided.
🌈 Inclusive Culture: “Total Self” culture—be your authentic self.
🏆 Recognition & Rewards: Peer appreciation and competitive total rewards program.

When diversity of thought, background, and perspective come together—everyone belongs, and innovation thrives.

🎯 Key Responsibilities

Conduct on-site and remote monitoring of clinical research studies to ensure compliance with ICH-GCP, protocols, and regulations.
Review key study documents: protocols, informed consent forms (ICF), and case report forms (CRFs).
Develop and implement tools, templates, and monitoring plans to ensure quality oversight.
Contribute to the design, implementation, and improvement of SOPs, processes, and training materials.
Manage project components such as:
- 🗂️ Site visit coordination
- 📊 Study progress tracking
- ⚠️ Issue identification and resolution
Ensure accurate documentation of monitoring activities: reports, letters, and action plans.
Collaborate with cross-functional teams, including investigators and site staff, to ensure smooth trial execution.

🎓 Qualifications

Education: Bachelor’s degree in a related field (or equivalent experience).
Experience: 2–4 years in clinical research monitoring.
Knowledge:
- Good Clinical Practice (ICH-GCP)
- Global regulatory requirements
Technical: Proficient in Clinical Trial Management Systems (CTMS) and related tools.
Soft Skills: Excellent communication, time management, and multitasking abilities.

🏅 Certifications (Preferred)

Certified Clinical Research Associate (CCRA) or equivalent certification.

🧠 Core Skills

🕵️ Attention to detail and analytical thinking
🧩 Problem-solving and critical reasoning
👥 Team collaboration and independence
⏰ Strong organizational and time management skills
💻 Proficiency in Microsoft Office Suite

💼 Compensation & Benefits

Syneos Health provides a comprehensive benefits package and quality work-life balance:

✅ Company Car or Car Allowance
✅ Health Coverage: Medical, Dental, Vision
✅ Retirement: 401(k) with company match
✅ Stock Options: Employee Stock Purchase Plan
✅ Incentives: Commission / Bonus Eligibility
✅ Time Off: Flexible PTO and Sick Leave

Paid sick time eligibility may vary based on local/state requirements.

💰 Salary Range: Varies based on qualifications, skills, and experience.

🌎 About Syneos Health’s Impact

Over the past 5 years, Syneos Health has:

Partnered on 94% of all Novel FDA-Approved Drugs
Supported 95% of EMA Authorized Products
Conducted 200+ Studies across 73,000 Sites and 675,000+ Trial Patients

Learn more 🔗 syneoshealth.com

⚙️ Additional Information

Tasks and responsibilities may evolve per business needs.
Equivalent experience/education may substitute for formal requirements.
Syneos Health is an equal opportunity employer, compliant with:
- EU Equality Directive
- ADA (Americans with Disabilities Act) – providing reasonable accommodations.

This description does not constitute a contract of employment.

🧭 Role Summary

Job Family: Clinical Monitoring / CRA (P21 Level)

Purpose:
Ensure clinical research studies are conducted with integrity, compliance, and quality.

Scope:

Conduct on-site & remote monitoring
Develop and implement quality monitoring tools
Manage defined project components
Contribute to process design, SOPs, and policies

Impact:
Your role ensures data reliability, protocol adherence, and trial excellence—ultimately driving innovation and better patient outcomes.

🎯 Core Focus Areas

✅ Comprehensive monitoring (on-site & remote)
🧩 Development of quality tools & procedures
🧭 Process management & documentation
🎓 Application of professional expertise
🧱 Upholding clinical excellence standards

📩 Apply Now

🔗 [Apply for this Job]

Not ready to apply?
Join our Talent Network to stay informed about new opportunities.

🫶 Commitment to Diversity

At Syneos Health, we value diversity, inclusion, and authenticity.
Even if your experience doesn’t perfectly align, apply anyway—your transferable skills matter.

Join us and make a meaningful impact. 🌍

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Clinical Research Associate Ii / Sr Cra - Full Service - Onc + Gen Med (Home-Based In Western Us)

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