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

0-2 years

Not Disclosed

Remote, USA

10 Nov. 20, 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 US (Idaho-Based)

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

Position Overview

Syneos Health is seeking an experienced Senior Clinical Research Associate (Sponsor-Dedicated) to support Rare Disease clinical programs across the Western United States. This remote role is ideal for candidates based in Idaho or nearby Western states with advanced expertise in clinical monitoring, protocol compliance, and cross-functional coordination.

As a global biopharmaceutical solutions organization operating in more than 110 countries, Syneos Health integrates clinical, medical, and commercial insights to accelerate the delivery of innovative therapies.

Key Responsibilities

Conduct on-site and remote monitoring visits to ensure full adherence to study protocols, ICH-GCP standards, and regulatory requirements.
Review case report forms, source documents, and regulatory files for accuracy and completeness.
Develop and refine monitoring tools, SOPs, checklists, and quality processes to support consistent trial oversight.
Provide operational input into process design, implementation, and study execution across assigned programs.
Mentor and supervise junior CRAs, providing guidance on monitoring practices and protocol compliance.
Perform study audits, identify deviations, and implement corrective and preventive action plans.
Maintain comprehensive and timely monitoring documentation, including visit reports, follow-up letters, communication records, and study trackers.
Manage clinical issues including protocol deviations, data inconsistencies, and safety events.
Collaborate closely with project managers, data managers, regulatory affairs, biostatistics, and site personnel to ensure trial success.
Support inspection readiness and verify accuracy of ISF–TMF reconciliation at study sites.

Required Qualifications and Experience

Bachelor’s degree in life sciences or a related field.
Minimum 5 years of clinical research monitoring experience, with demonstrated progression from Senior CRA I or equivalent role.
Strong understanding of ICH-GCP guidelines, regulatory frameworks, clinical operations, and site management.
Proven experience in Oncology and Rare Disease therapeutic areas.
Ability to work independently while managing multiple complex protocols and study sites.
Strong scientific knowledge base with advanced analytical and problem-solving skills.
Excellent communication, documentation, and stakeholder management abilities.
Proficiency with clinical trial management systems (CTMS), EDC platforms, and monitoring software.
Willingness and ability to travel for on-site monitoring as needed.

Preferred Certifications

Certified Clinical Research Associate (CCRA) or equivalent certification is preferred.

Core Competencies

Strong organizational and time-management capabilities.
High level of accuracy, documentation discipline, and attention to detail.
Ability to coordinate site-level activities, ensure informed consent compliance, and maintain participant confidentiality.
Experience verifying investigational product handling, EDC compliance, and ISF/TMF alignment.
Capability to support site readiness for audits and regulatory inspections.

Compensation and Benefits

Syneos Health provides competitive total rewards, which may include:

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

Salary Range

The base salary range reflects Syneos Health’s anticipated low and high values for this role. Final compensation depends on qualifications, relevant skills, and demonstrated competencies.

About Syneos Health

Over the past five years, Syneos Health has contributed to:

94 percent of FDA-approved novel therapies
95 percent of EMA-authorized products
More than 200 global clinical studies across 73,000 sites and 675,000 participants

The organization promotes an inclusive, development-focused culture and supports career progression through technical training, leadership opportunities, and global collaboration.

Additional Information

Responsibilities listed may not be exhaustive. Syneos Health may assign additional duties at its discretion. Equivalent education or experience will be considered where applicable. The company complies with the Americans with Disabilities Act and provides reasonable accommodations as needed.

This role sits within the Clinical Monitoring/CRA P22 job family and directly contributes to the quality, safety, documentation integrity, and regulatory compliance of clinical research programs.

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

Job Description

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