Senior Clinical Research Associate – Sponsor Dedicated (Rare Disease) | Remote, Western USA
Location: USA – OR – Remote
Updated: November 14, 2025
Job ID: 25103433
Employment Type: Full-Time
Syneos Health, a leading global biopharmaceutical solutions provider, is seeking a Senior Clinical Research Associate (CRA) to support Rare Disease studies in a sponsor-dedicated, home-based role across the Western United States. This is an opportunity to work within a high-performance clinical development environment with strong career advancement potential.
About Syneos Health
Syneos Health integrates clinical and commercial expertise to accelerate customer success. With 29,000 employees across 110+ countries, the company delivers clinical, medical affairs, and commercial solutions for global biotech and pharmaceutical partners.
Syneos Health promotes a Total Self culture that supports authenticity, diversity, and personal well-being, ensuring employees thrive in a collaborative and inclusive environment.
Position Overview
The Senior CRA is responsible for independently monitoring clinical trials, ensuring compliance with ICH-GCP guidelines, regulatory requirements, protocol adherence, and sponsor standards. This role involves both on-site and remote monitoring with a focus on Rare Disease and Oncology therapeutic areas.
Key Responsibilities
Conduct on-site and remote monitoring visits, including initiation, interim, and close-out activities.
Review study protocols, CRFs, ICFs, regulatory documents, and clinical data to ensure adherence to global clinical practices.
Develop monitoring tools, checklists, and processes to ensure inspection-ready quality.
Provide operational and technical oversight to junior CRAs, supporting training and mentoring as required.
Perform source data verification, query resolution, protocol deviation assessment, and safety review of trial data.
Ensure IP accountability, storage, reconciliation, and compliance with regulatory requirements.
Maintain accurate documentation including monitoring reports, follow-up letters, trip reports, and communication logs.
Serve as primary liaison with site personnel, ensuring robust site management and continuous audit readiness.
Collaborate cross-functionally with project managers, data managers, biostatisticians, and regulatory teams.
Identify site-level risks, recommend corrective and preventive actions, and support issue escalation.
Required Qualifications
Bachelor’s degree in a life sciences or related field.
Minimum 5 years of clinical research monitoring experience, including progression from Senior CRA I.
Strong understanding of ICH-GCP, regulatory requirements, and clinical trial operations.
Experience in Oncology and Rare Disease studies.
Strong analytical, problem-solving, and communication skills.
Ability to work independently and manage multiple priorities.
Proficiency with CTMS, EDC, and other clinical trial systems.
Ability to travel for on-site monitoring as required.
Preferred Qualifications
Certified Clinical Research Associate (CCRA) or equivalent credential.
Additional Information
Syneos Health offers competitive compensation, career progression, and benefits including medical, dental, vision coverage, 401(k) with company match, employee stock purchase plan, car allowance, performance bonuses, and flexible paid time off. Benefits may vary depending on employment location.
Actual salary will be based on experience, skills, and role-specific competencies.
The company complies with federal, state, and local employment and equal opportunity regulations, including ADA reasonable accommodations.
Summary
This role is part of the Clinical Monitoring/CRA job family at the P22 level, responsible for ensuring data integrity, protocol compliance, subject safety, and high-quality study execution. The Senior CRA contributes to site qualification, monitoring, documentation, and process improvement, while serving as a critical link between the sponsor and investigational sites.
Apply Now
Advance your clinical research career by joining a global leader committed to scientific excellence and patient-centric outcomes.
Apply for this position or join the Syneos Health Talent Network to explore additional opportunities.
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