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

5+ years

Not Disclosed

Remote, USA

10 Nov. 27, 2025

Job Description

Job Type: Full Time Remote 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 (Remote, Western United States)

Location: USA – Western Region (Home-Based)
Updated: November 14, 2025
Job ID: 25103433
Employment Type: Full-Time
Experience Required: Minimum 5 years of clinical research monitoring experience (Senior CRA level and above)

Job Overview

Syneos Health is seeking an experienced Senior Clinical Research Associate (CRA) to support sponsor-dedicated Rare Disease studies across the Western United States. This position is fully remote and requires advanced expertise in clinical monitoring, regulatory compliance, and cross-functional collaboration.

Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions provider, partnering with leading organizations to accelerate clinical development and improve patient outcomes. With a presence in 110 countries and a network of over 29,000 professionals, the company is committed to transforming the clinical research landscape.

Key Responsibilities

Perform on-site and remote monitoring to ensure compliance with protocols, ICH-GCP, and regulatory guidelines.
Review study protocols, case report forms, investigational plans, and essential regulatory documentation.
Develop monitoring tools, SOPs, checklists, and quality oversight frameworks.
Provide expert input during process design, implementation, and review stages.
Lead and mentor junior CRAs; manage specific site-level process oversight.
Conduct audits, inspections, and compliance reviews, addressing deviations and implementing CAPAs.
Maintain accurate, detailed monitoring reports and study documentation within designated systems.
Identify and resolve discrepancies, adverse events, and protocol non-compliance.
Collaborate with cross-functional teams including project management, data management, biostatistics, and regulatory affairs.
Ensure investigational product accountability, including storage, reconciliation, and security.
Oversee site training, readiness, and communication to meet trial milestones and regulatory expectations.
Maintain, review, and reconcile Investigator Site Files with the Trial Master File.

Qualifications

Bachelor’s degree in a life science or related field.
Minimum of 5 years of clinical research monitoring experience (progression from Senior CRA I preferred).
Deep understanding of clinical trial processes, GCP, ICH guidelines, and regulatory frameworks.
Strong scientific and analytical background.
Experience in Oncology and/or Rare Disease clinical trials.
Proficiency in CTMS, EDC, and other clinical trial systems.
Excellent communication, organization, and problem-solving skills.
Ability to manage multiple priorities and work independently.
Willingness to travel for on-site monitoring visits.

Preferred Certifications

Certified Clinical Research Associate (CCRA) or equivalent credential.

Skills and Competencies

Strong attention to detail and documentation accuracy.
Advanced knowledge of clinical operations, monitoring techniques, and quality systems.
Ability to train, supervise, and mentor junior CRAs.
Consistent adherence to regulatory, ethical, and organizational standards.

Compensation & Benefits

Syneos Health offers competitive benefits, which may include:

Company car or car allowance
Medical, dental, and vision coverage
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based commissions or bonuses
Flexible PTO and regulated paid sick leave
Supportive career development, training, and progression pathways

Actual compensation may vary based on qualifications, experience, and skills.

About Syneos Health

In the last five years, Syneos Health has contributed to:

94% of all FDA-approved novel drugs
95% of EMA-authorized products
200+ global studies across 73,000 sites and over 675,000 patients

The company emphasizes authenticity, diversity, and continuous development through its Total Self culture.

Additional Information

Syneos Health may adjust responsibilities or qualifications in accordance with business needs. Equivalent experience or education may be considered. The organization complies fully with ADA requirements and global employment legislation.

Summary

This role plays a crucial part in ensuring the integrity, quality, and operational success of Rare Disease clinical trials. Senior CRAs at this level drive site performance, safeguard participant safety, maintain data accuracy, support audit readiness, and provide leadership within the clinical monitoring function.

Apply Now

Submit your application through the Syneos Health careers portal.

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

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