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

0-2 years

Not Disclosed

Remote

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 (Idaho)
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 globally. By combining clinical, medical affairs, and commercial insights, Syneos Health provides innovative solutions that address the evolving demands of modern healthcare.

Our Clinical Development model places the patient and client at the center of every decision. Whether in a Full-Service or Functional Service Provider partnership, our teams collaborate to deliver high-quality clinical programs efficiently and effectively.

Role Overview

We are seeking a Clinical Research Associate II / CRA I to join our sponsor-dedicated team focused on Oncology and General Medicine clinical trials. This home-based position offers the opportunity to contribute to cutting-edge clinical research while ensuring regulatory compliance, quality, and integrity of clinical data.

The role is ideal for experienced clinical research professionals who are capable of remote and on-site monitoring, proactive issue resolution, and collaboration across cross-functional teams.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, and close-out visits in alignment with ICH-GCP, GPP, regulatory standards, and protocol requirements.
Assess site performance, escalate critical risks, and recommend corrective actions to project teams.
Verify informed consent procedures, protect patient confidentiality, and monitor patient safety and data integrity.
Perform source document verification and ensure accurate entry of clinical data in case report forms (CRFs).
Apply query resolution techniques, both remotely and on-site, ensuring timely closure of data queries.
Manage investigational product (IP) accountability, including storage, dispensing, reconciliation, and compliance with blinded/randomized procedures.
Maintain and reconcile Investigator Site Files (ISF) with the Trial Master File (TMF), ensuring documentation meets local and global regulatory standards.
Support patient recruitment, retention, and awareness strategies, including tracking progress in project systems.
Serve as a primary liaison for site personnel and collaborate with Central Monitoring Associates when applicable.
Participate in Investigator Meetings, sponsor meetings, and ongoing clinical training sessions.
Provide guidance on audit readiness and support site and project-level audit preparations.
For Real World Late Phase studies, support site identification, chart abstraction, and collaboration with sponsor affiliates, medical science liaisons, and local staff.
Train junior site management staff and proactively recommend potential sites based on local treatment trends and healthcare 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.
Thorough knowledge of ICH-GCP Guidelines, clinical research regulations, and SOPs.
Proficiency with electronic data capture systems and clinical monitoring technologies.
Strong communication, presentation, and organizational 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 techniques.

Compensation & Benefits

Syneos Health offers competitive salaries, commensurate with experience and qualifications. Eligible benefits include:

Comprehensive Medical, Dental, and Vision insurance
Company match 401(k) and Employee Stock Purchase Plan
Performance-based bonuses
Flexible paid time off and sick leave policies
Company car or car allowance (role-dependent)

Actual compensation varies based on skills, experience, and location.

Why Join Syneos Health?

Work for a global organization impacting over 675,000 trial patients across 73,000 sites.
Engage in a diverse, inclusive culture supporting career growth and continuous learning.
Contribute to innovative clinical solutions with meaningful patient outcomes.
Thrive in a remote-friendly, flexible work environment.

Additional Information

This job description is not exhaustive; Syneos Health may assign additional tasks or responsibilities as required. Equivalent experience, education, or skills may be considered. The company is committed to compliance with all employment laws, including the Americans with Disabilities Act (ADA) and equal opportunity regulations.

Apply Now to join Syneos Health’s global team of clinical research professionals or join our Talent Network to receive 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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