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

5+ years
Not Disclosed
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 (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.