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

2-4 years

Not Disclosed

Remote, USA

10 Nov. 19, 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

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

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

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development and improving patient outcomes worldwide. By leveraging unique clinical, medical affairs, and commercial insights, Syneos Health delivers innovative solutions to address modern healthcare challenges.

Our patient- and client-centric Clinical Development model emphasizes collaboration, efficiency, and quality. Whether in a Full-Service or Functional Service Provider model, our teams innovate to streamline clinical trials, ensuring faster delivery of therapies that improve lives.

Role Summary

We are seeking an experienced Clinical Research Associate II / CRA I to join our sponsor-dedicated team focused on Oncology (ONC) and General Medicine trials. This home-based role in Arizona offers the opportunity to oversee clinical trial sites remotely and on-site, ensuring compliance with regulatory standards, protocol adherence, and high-quality data collection.

The ideal candidate is proactive, detail-oriented, and capable of managing multiple clinical sites, collaborating with cross-functional teams, and supporting patient recruitment and retention strategies.

Key Responsibilities

Perform site qualification, initiation, interim monitoring, and close-out visits (remote or on-site) in compliance with ICH-GCP, GPP, local regulations, and study protocols.
Assess site performance, identify risks, escalate critical issues, and develop corrective action plans.
Verify informed consent procedures and protect patient confidentiality. Monitor patient safety and ensure clinical data integrity.
Conduct source document verification and ensure accuracy of case report form (CRF) data.
Resolve queries, provide guidance to site staff, and drive timely closure of data issues.
Manage investigational product (IP) accountability, including storage, dispensing, reconciliation, labeling, import/export, and adherence to blinded/randomized protocols.
Maintain Investigator Site Files (ISF) and reconcile with Trial Master File (TMF) per regulatory standards.
Document all site activities, including confirmation letters, trip reports, and communication logs, in compliance with SOPs and Clinical Monitoring Plans.
Support patient recruitment, retention, and awareness programs.
Act as liaison with site personnel and collaborate with Central Monitoring Associates as needed.
Participate in investigator meetings, sponsor meetings, and required training sessions.
Ensure site and project audit readiness and support follow-up actions.
For Real World Late Phase studies, provide site lifecycle support, chart abstraction, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.
Mentor junior staff and recommend sites based on local treatment patterns and healthcare provider networks.

Required Qualifications & Experience

Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or related field.
CRA I: Minimum 1 year of clinical monitoring experience in a regulated environment.
CRA II: Minimum 2–4 years of independent clinical monitoring experience.
Strong knowledge of ICH-GCP Guidelines, SOPs, and clinical research regulations.
Proficiency with electronic data capture systems and clinical monitoring technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel up to 75%, including remote and on-site visits.

Preferred Qualifications

Experience in Oncology and General Medicine clinical trials.
Knowledge of real-world evidence or late-phase study designs.
Familiarity with risk-based monitoring and patient recruitment strategies.

Compensation & Benefits

Competitive salary based on experience and qualifications.
Health benefits: Medical, Dental, Vision.
Retirement benefits: 401(k) match, Employee Stock Purchase Plan.
Performance-based bonuses and flexible paid time off (PTO).
Company car or car allowance (if applicable).

Why Join Syneos Health?

Contribute to global clinical trials impacting over 675,000 patients across 73,000 sites.
Thrive in a diverse, inclusive, and supportive work culture.
Advance your career through continuous learning, training, and mentoring opportunities.
Work in a remote-friendly, flexible environment with meaningful responsibilities.

Additional Information

This job description is not exhaustive; additional responsibilities may be assigned as required. Equivalent education, experience, or skills may be considered. Syneos Health complies with all applicable employment laws, including the Americans with Disabilities Act (ADA) and equal opportunity regulations.

Apply Now to join Syneos Health’s global clinical research team or join our Talent Network for updates on future opportunities.

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

Job Description

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