Senior Clinical Research Associate - Sponsor Dedicated - Rare Disease (Home-Based In Western Us)

5+ years

Not Disclosed

Remote, USA

10 Nov. 20, 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

Senior Clinical Research Associate (Sponsor-Dedicated) – Rare Disease | Home-Based in Western US

Updated: November 14, 2025
Location: USA-OR-Remote
Job ID: 25103433

About the Role

Syneos Health is seeking a Senior Clinical Research Associate (Sponsor-Dedicated) specializing in Rare Disease studies. This is a fully remote position based in the Western United States. The role supports end-to-end clinical monitoring activities, ensuring that clinical trials are executed to the highest standards of compliance, quality, and operational efficiency.

Syneos Health is a global biopharmaceutical solutions organization operating in more than 110 countries, partnering with pharmaceutical, biotechnology, and medical device companies to accelerate clinical development.

Key Responsibilities

Conduct on-site and remote monitoring visits to ensure full compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
Review case report forms, source documents, regulatory submissions, and site documentation for accuracy and completeness.
Develop and maintain monitoring tools, checklists, SOPs, and standardized processes to support high-quality trial oversight.
Provide expert input into process development, study implementation, and operational strategy across assigned programs.
Mentor and guide junior CRAs, oversee their monitoring activities, and support training and development.
Perform routine audits and inspections, identify compliance issues, and implement corrective and preventive actions.
Maintain detailed documentation of monitoring activities, including progress reports, follow-up letters, and database updates.
Investigate and resolve protocol deviations, data discrepancies, and adverse event reporting issues.
Collaborate with cross-functional teams including data management, biostatistics, regulatory affairs, and project management.
Ensure site readiness for inspections and support all audit-related activities.

Required Qualifications and Experience

Bachelor’s degree in life sciences or related field required.
Minimum 5 years of clinical research monitoring experience; progression from Senior CRA I preferred.
Strong understanding of clinical trial methodologies, ICH-GCP guidelines, and regulatory frameworks.
Demonstrated experience in Oncology and Rare Disease therapeutic areas.
Proven ability to manage multiple sites and complex study protocols independently.
Excellent analytical, problem-solving, communication, and interpersonal skills.
Ability to work autonomously in a fast-paced and highly regulated environment.
Proficiency in clinical trial management systems, EDC platforms, and standard monitoring tools.
Ability to travel as required for on-site monitoring.

Preferred Certifications

Certified Clinical Research Associate (CCRA) or equivalent professional certification.

Core Competencies

Strong organizational and time-management abilities.
High attention to detail and accuracy.
Capability to support audit readiness across all assigned sites.
Ability to coordinate with investigator site staff, providing guidance on compliance and study procedures.
Skill in reviewing Investigator Site Files (ISF) and reconciling with the Trial Master File (TMF).

Compensation and Benefits

Syneos Health offers a competitive and comprehensive benefits package that may include:

Medical, Dental, and Vision insurance
Company car or car allowance
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based bonuses or commissions
Flexible paid time off and paid sick leave (varies by state)

Salary Range

Compensation will vary based on experience, skills, and qualifications. The base salary range reflects the anticipated low and high values for this position.

About Syneos Health

Syneos Health has contributed to:

94% of FDA-approved novel therapies over the past five years
95% of EMA-authorized products
More than 200 global studies across 73,000+ sites and 675,000+ trial participants

The organization fosters an inclusive workplace focused on career advancement, professional development, and a supportive culture built around authentic engagement and diversity of thought.

Additional Information

This job description is not exhaustive. Responsibilities may be updated based on organizational needs. Equivalent education and experience will be considered. Syneos Health complies with ADA requirements and provides reasonable accommodations where appropriate.

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Senior Clinical Research Associate - Sponsor Dedicated - Rare Disease (Home-Based In Western Us)

Job Description

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