Clinical Research Associate Ii / Cra I - Sponsor Dedicated - Onc + Gen Med (Home-Based In Western Us)

0-2 years

Not Disclosed

Remote, USA

10 Nov. 19, 2025

Job Description

Job Type: Full Time 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

Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine)

Location: Remote – Western United States (Nevada)
Job ID: 25103340
Updated: November 14, 2025

Company Overview

Syneos Health® is a leading global biopharmaceutical solutions organization, delivering integrated clinical, medical affairs, and commercial services to accelerate therapeutic development and improve patient outcomes. By leveraging unique insights and innovative solutions, Syneos Health drives efficiency and effectiveness across clinical trials, providing transformative solutions for modern healthcare.

Our Clinical Development model places patients and clients at the center of our operations. Through Full-Service and Functional Service Provider (FSP) engagements, team members collaborate to design, execute, and optimize clinical research strategies that enhance study quality and speed to market.

Position Overview

We are seeking an experienced Clinical Research Associate II / CRA I to provide sponsor-dedicated monitoring support for Oncology (ONC) and General Medicine studies. This home-based role in Nevada requires oversight of clinical sites, ensuring regulatory compliance, patient safety, and high-quality data integrity.

This role involves monitoring multiple sites, mentoring junior staff, collaborating with global teams, and applying risk-based monitoring and data-driven techniques to identify and resolve issues proactively.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, and close-out visits (remote or on-site) while ensuring adherence to ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site and staff performance; escalate critical issues; develop corrective and preventive action plans.
Ensure proper informed consent procedures and maintain patient confidentiality. Monitor safety and clinical data integrity.
Conduct source document verification and confirm CRF accuracy and completeness.
Manage query resolution both remotely and on-site, guiding site staff to timely resolution.
Oversee investigational product (IP) accountability, including storage, reconciliation, labeling, and protocol compliance.
Maintain and reconcile Investigator Site Files (ISF) with Trial Master File (TMF).
Document monitoring activities through reports, letters, and logs, supporting recruitment and retention strategies.
Act as a primary liaison with site personnel, collaborate with Central Monitoring Associates, and ensure site compliance with study requirements.
Participate in investigator meetings, sponsor interactions, and global clinical training sessions.
Provide guidance for audit readiness and assist in audit preparation and follow-up activities.
For Real-World Late Phase studies, support site lifecycle management, chart abstraction, and collaboration with sponsor affiliates.
Mentor junior staff and provide local insights to optimize study conduct and patient recruitment.

Qualifications & Experience

Bachelor’s degree or RN in Life Sciences, Nursing, Pharmacy, or a related field.
CRA I: Minimum 1 year clinical monitoring experience.
CRA II: Minimum 2–4 years independent clinical monitoring experience.
Strong knowledge of ICH-GCP guidelines, SOPs, and regulatory requirements.
Proficient with electronic data capture (EDC) systems, clinical monitoring software, and data management tools.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75% for site visits.

Preferred Skills

Prior experience in Oncology and General Medicine clinical trials.
Familiarity with risk-based monitoring and real-world evidence studies.
Experience mentoring junior clinical staff.

Compensation & Benefits

Competitive salary aligned with experience and qualifications.
Comprehensive health benefits: Medical, Dental, Vision.
401(k) match and Employee Stock Purchase Plan eligibility.
Performance-based bonuses and incentives.
Flexible paid time off (PTO) and sick leave.
Company car or allowance where applicable.

Why Join Syneos Health?

Work with a global network supporting over 675,000 patients across 73,000 clinical sites.
Thrive in a diverse, inclusive, and collaborative work environment.
Access comprehensive career development, mentorship, and clinical training programs.
Contribute to high-impact clinical research shaping the future of patient care worldwide.

Additional Information

Responsibilities outlined are not exhaustive and may evolve. Equivalent experience, skills, or education will be considered. Syneos Health is committed to ADA compliance and provides reasonable accommodations as required.

Apply now to join a leading global clinical research organization, or join our Talent Network to explore future opportunities.

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Clinical Research Associate Ii / Cra I - Sponsor Dedicated - Onc + Gen Med (Home-Based In Western Us)

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