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

1-4 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 (New Mexico)
Job ID: 25103340
Updated: November 14, 2025

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization delivering innovative clinical, medical affairs, and commercial services globally. With a focus on accelerating therapy development and improving patient outcomes, we combine expertise and data-driven insights to address modern healthcare challenges.

Our Clinical Development model prioritizes patients and clients, optimizing processes to streamline collaboration and enhance efficiency. Team members operate in Full-Service and Functional Service Provider (FSP) environments, contributing to innovative solutions that transform clinical research.

Position Summary

Syneos Health is seeking an experienced Clinical Research Associate II / CRA I to provide sponsor-dedicated support for Oncology (ONC) and General Medicine trials. This remote, home-based role in New Mexico focuses on clinical site monitoring, regulatory compliance, patient safety, and data integrity. The role requires professionals capable of managing multiple sites, mentoring junior staff, and collaborating effectively with cross-functional teams.

Key Responsibilities

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

Qualifications & Experience

Bachelor’s degree or RN in Life Sciences, Nursing, Pharmacy, or 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.
Proficiency with electronic data capture (EDC) systems and clinical monitoring tools.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75% for site visits.

Preferred

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

Why Join Syneos Health?

Collaborate with a global network supporting over 675,000 patients across 73,000 clinical sites.
Thrive in a diverse, inclusive, and supportive work environment.
Access extensive career development, mentorship, and training programs.
Contribute to cutting-edge clinical research impacting patient outcomes worldwide.

Additional Information

This job description is not exhaustive; duties may evolve. Equivalent experience, skills, or education will be considered. Syneos Health complies with the Americans with Disabilities Act (ADA) 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)

Job Description

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