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

2-4 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 – Oncology & General Medicine

Location: Western United States (Home-Based)
Job Type: Full-Time | Remote
Company: Syneos Health
Job ID: 25103340
Updated: November 14, 2025

Job Overview

Syneos Health is seeking a highly skilled Clinical Research Associate II / CRA I to join its sponsor-dedicated team supporting Oncology and General Medicine studies. This remote role is based in the Western United States and requires strong expertise in clinical monitoring, regulatory compliance, and site management within global clinical trials.

This position is ideal for professionals who want to grow within a leading biopharmaceutical solutions organization known for innovation, operational excellence, and patient-centric research delivery.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits in compliance with ICH-GCP, regulatory standards, and study protocols.
Evaluate site performance, identify issues, escalate critical findings, and develop corrective action plans in collaboration with project teams.
Verify informed consent procedures, maintain subject data confidentiality, and monitor safety-related parameters.
Perform Source Document Review, validate Case Report Form entries, resolve data queries, and support sites in achieving timely data completion.
Oversee investigational product accountability, storage, security, labeling, and reconciliation.
Maintain and audit the Investigator Site File (ISF) to ensure completeness and reconciliation with the Trial Master File (TMF).
Document all monitoring activities through confirmation letters, trip reports, communication logs, and other study-required documentation.
Support subject recruitment, site engagement, and retention strategies aligned with monitoring and project plans.
Train site teams, liaise with Central Monitoring Associates, and participate in Investigator Meetings and sponsor meetings.
Contribute to audit readiness activities and support follow-up actions.
For Real World Late Phase (RWLP) projects, support chart abstraction, data collection, and collaboration with local country teams and medical science liaisons.

Required Qualifications & Experience

Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or related field.
Minimum 2 to 4 years of clinical monitoring or clinical research experience (for CRA II); 1+ year for CRA I.
Strong knowledge of ICH-GCP, FDA/EMA regulations, and applicable global regulatory standards.
Proficiency in electronic data capture systems and digital monitoring platforms.
Excellent communication, organizational, and analytical skills.
Ability to travel up to 75% as required.
Ability to work independently, manage multiple priorities, and adapt to changing project needs.

Preferred Skills

Oncology or General Medicine therapeutic experience.
Experience in remote monitoring and risk-based monitoring methodologies.
Prior site management and sponsor-dedicated experience.

Compensation and Benefits

Syneos Health provides competitive compensation aligned with candidate qualifications, skills, and experience. Benefits may include:

Medical, Dental, and Vision coverage
401(k) with company match
Employee Stock Purchase Plan
Performance-based bonus/commission eligibility
Company car or car allowance (role-dependent)
Flexible paid time off and sick leave (based on state regulations)

About Syneos Health

Syneos Health is a global leader in integrated biopharmaceutical solutions, operating across 110 countries with more than 29,000 professionals. Over the past five years, the organization has contributed to 94 percent of FDA-approved novel drugs and 95 percent of EMA-authorized products.

Its commitment to development, diversity, inclusion, and continuous innovation makes it an employer of choice for clinical research professionals.

Equal Opportunity Statement

Syneos Health is committed to creating an inclusive, diverse, and accessible workplace. Candidates with transferable skills are encouraged to apply, even if their experience does not meet every requirement.

Apply Now

Interested candidates can submit their application through the Syneos Health career portal.

Not ready to apply? Join the Syneos Health 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)

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