Senior Clinical Research Associate (CRA) – Sponsor Dedicated, Rare Disease | Remote (Western US)
Updated: November 14, 2025
Location: USA – NM – Remote
Job ID: 25103433
Overview
Syneos Health is a global, fully integrated biopharmaceutical solutions organization committed to accelerating clinical development and enhancing sponsor success. With a strong focus on clinical, medical affairs, and commercial capabilities, the company is recognized for delivering efficient, high-quality outcomes built around patient and customer needs.
As a Senior Clinical Research Associate (Sponsor Dedicated) in the Rare Disease therapeutic area, you will play a central role in the monitoring and oversight of clinical trials across Western United States. This position is home-based and requires strong expertise in clinical research monitoring, compliance, and operational excellence.
Key Responsibilities
Conduct on-site and remote monitoring visits, ensuring adherence to clinical trial protocols, SOPs, regulatory requirements, and ICH-GCP guidelines.
Review study protocols, case report forms, regulatory documents, and site processes for compliance and quality assurance.
Develop and implement monitoring tools, checklists, and SOPs to support continuous quality improvement.
Provide technical input during the design and execution of clinical processes, programs, and policies.
Mentor, guide, and support junior CRAs, supervising their activities where applicable.
Perform regular audits, resolve compliance issues, and ensure corrective and preventive actions (CAPA) are implemented.
Maintain comprehensive documentation, including monitoring reports, progress updates, and communication logs.
Identify protocol deviations, data discrepancies, and safety concerns, escalating as required.
Collaborate with cross-functional teams including project management, data management, biostatistics, and regulatory affairs.
Ensure IP accountability, source document verification, EDC compliance, and ISF/TMF reconciliation.
Act as a primary liaison with site personnel and ensure readiness for audits and inspections.
Qualifications
Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
Minimum 5 years of clinical research monitoring experience, with proven capability at a Senior CRA level.
Strong understanding of clinical trial operations, regulatory requirements, and ICH-GCP guidelines.
Experience in Oncology and Rare Disease studies required.
Excellent communication skills, analytical ability, and problem-solving capabilities.
Ability to work independently within a remote environment while coordinating with global teams.
Strong organizational skills and detail orientation.
Ability to travel for site visits as needed.
Preferred Certifications
Certified Clinical Research Associate (CCRA) or equivalent professional qualification.
Technical Skills
Proficiency in Clinical Trial Management Systems (CTMS) and EDC tools.
Strong documentation and reporting skills.
Ability to manage multiple priorities and timelines effectively.
Compensation and Benefits
Syneos Health offers competitive compensation packages, including:
Base salary (range dependent on experience, skills, and competencies)
Medical, dental, and vision insurance
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based bonuses and commissions (role-dependent)
Company car or car allowance (where applicable)
Flexible paid time off and sick leave compliant with state/local regulations
About Syneos Health
Over the last five years, Syneos Health has collaborated with a majority of global pharmaceutical innovators, contributing to:
94% of all FDA-approved novel drugs
95% of EMA-authorized products
200+ studies across 73,000 sites with over 675,000 trial participants
Syneos Health fosters a culture built on professional development, diversity, inclusion, and global collaboration.
Additional Information
This job description outlines primary responsibilities but is not exhaustive. The company may modify duties based on business needs. Equivalent experience or education may be considered. Syneos Health is committed to compliance with ADA and providing reasonable accommodations.
Core Functional Focus
Regulatory and protocol compliance across all monitoring activities
Site performance evaluation and strategic recommendations
Source document review and clinical data validation
IP accountability and EDC compliance
ISF and TMF accuracy, completeness, and reconciliation
Audit readiness, site-level communication, and CRA mentorship
How to Apply
Qualified candidates are encouraged to submit their application through the official Syneos Health careers portal.
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