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

1-2 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 and General Medicine)

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

Position Overview

Syneos Health is recruiting a Clinical Research Associate II / CRA I to support sponsor-dedicated clinical programs in Oncology and General Medicine. This is a fully remote role based in the Western United States, offering an excellent opportunity to work with a globally recognized biopharmaceutical solutions provider known for advancing complex clinical research across 110 countries.

The position is suited for experienced clinical research professionals who can independently manage monitoring activities, ensure regulatory compliance, and support high-quality study execution in partnership with global project teams.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, management, and close-out visits in accordance with ICH-GCP, regulatory standards, and study protocols.
Evaluate site performance, identify issues, escalate critical risks, and support corrective action planning.
Verify informed consent documentation, protect subject confidentiality, and monitor subject safety and data integrity.
Perform Source Document Review, ensure CRF accuracy, resolve queries, and support sites in meeting data timelines.
Oversee investigational product accountability, storage, dispensing, reconciliation, and compliance with blinded/randomized processes.
Maintain and review the Investigator Site File (ISF) and reconcile it with the Trial Master File (TMF).
Document all site interactions through confirmation letters, follow-up reports, trip reports, and internal communication logs.
Support patient recruitment and retention strategies.
Manage site-level timelines, deliverables, and communication aligned with project objectives.
Serve as site liaison and collaborate with Central Monitoring Associates as required.
Participate in Investigator Meetings, sponsor meetings, and clinical monitoring training.
Provide guidance on audit readiness and support audit response activities.
For Real World Late Phase studies: support site identification, chart abstraction, local regulatory requirements, and collaboration with local affiliates and medical teams.
Train junior site management staff (as applicable).
Identify potential new sites based on local treatment patterns and healthcare networks.

Required Qualifications and Experience

Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or related discipline.
CRA I: Minimum 1 year of clinical monitoring experience.
CRA II: Minimum 2 to 4 years of independent clinical monitoring experience.
Strong working knowledge of ICH-GCP, clinical research regulations, and site management processes.
Proficiency with electronic data capture systems and digital monitoring platforms.
Excellent communication, documentation, and organizational skills.
Ability to travel up to 75 percent as required.
Ability to adapt to changing priorities and deliver within fast-paced clinical development environments.

Preferred Skills

Prior experience in Oncology or General Medicine clinical trials.
Experience in real-world evidence or late-phase research.
Exposure to risk-based monitoring techniques.

Compensation and Benefits

Syneos Health offers competitive compensation aligned with candidate qualifications and experience. Eligible benefits may include:

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

Actual salary will vary based on skills, experience, location, and performance factors.

About Syneos Health

Syneos Health is a global leader in integrated clinical development and commercialization. Over the last five years, the company has contributed to 94 percent of FDA-approved novel therapies and 95 percent of EMA-authorized products while supporting more than 200 studies across 73,000 sites worldwide.

The organization is committed to professional development, diversity, inclusion, and a culture where employees can thrive and build impactful careers.

Additional Information

This job description is not exhaustive. Responsibilities may be adjusted based on business needs. Equivalent education, experience, or skills may be considered. Syneos Health adheres to all global employment regulations, including ADA and equal opportunity requirements.

Apply Now

Qualified candidates are encouraged to apply through the Syneos Health career portal.

Not ready to apply? Join the Syneos Health Talent Network to receive updates on upcoming roles.

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

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