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

5+ years

Not Disclosed

Remote, USA

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 (Sponsor Dedicated) – Rare Disease | Remote, Western US

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

Position Overview

Syneos Health, a globally recognized and fully integrated biopharmaceutical solutions organization, is seeking an experienced Senior Clinical Research Associate to support sponsor-dedicated clinical trials in the Rare Disease therapeutic area. This remote role, based in the Western United States, involves comprehensive site monitoring, study oversight, compliance assurance, and cross-functional collaboration.

The organization’s Clinical Development model places both the sponsor and patient at the center of every process, emphasizing streamlined operations, high-quality outcomes, and accelerated delivery of innovative therapies.

Key Responsibilities

Perform on-site and remote monitoring activities in accordance with study protocols, ICH-GCP guidelines, and regulatory requirements.
Review and assess case report forms, regulatory documentation, and site procedures to ensure high-quality clinical data and operational integrity.
Develop and refine monitoring plans, process checklists, and standard operating procedures to strengthen quality control.
Provide expert input during development of clinical processes, programs, and policies.
Train, mentor, and direct junior CRAs and other relevant staff, ensuring efficient workflow and compliance.
Execute routine audits and inspections, supporting sites in resolving compliance issues and implementing corrective actions.
Maintain accurate documentation, including monitoring visit reports, communication logs, confirmation letters, and database updates.
Identify and address protocol deviations, data inconsistencies, and trial-related concerns.
Work closely with cross-functional partners such as clinical project managers, data managers, biostatisticians, and regulatory affairs professionals.
Ensure timely oversight of investigational product accountability, EDC system compliance, and site-level documentation (ISF/TMF).
Serve as the primary liaison for site personnel and uphold audit-readiness standards.

Required Qualifications

Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline.
Minimum 5 years of clinical research monitoring experience, preferably with progression from CRA to Senior CRA level.
Strong background in Oncology and Rare Disease clinical trials.
Comprehensive understanding of clinical trial processes, GCP requirements, and regulatory expectations.
Demonstrated analytical, organizational, and problem-solving skills.
Ability to work independently within a remote setting while maintaining collaboration across distributed teams.
Excellent written and verbal communication skills.
Strong scientific and technical background.

Preferred Certifications

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

Technical Skills

Proficiency in CTMS, EDC platforms, and other clinical trial management software.
Ability to manage multiple studies, priorities, and timelines efficiently.
Strong attention to detail with an emphasis on quality documentation.
Willingness to travel for routine and targeted site monitoring visits.

Compensation and Benefits

Syneos Health provides competitive and comprehensive benefits, including:

Base salary (range varies depending on skills, experience, and competency)
Medical, dental, and vision insurance
Company-matched 401(k) plan
Employee Stock Purchase Plan eligibility
Performance-based bonus opportunities
Company car or car allowance where applicable
Flexible paid time off and paid sick leave in accordance with federal, state, and local regulations

About Syneos Health

Syneos Health has partnered with a majority of leading pharmaceutical organizations, contributing to:

94% of FDA-approved novel therapies
95% of EMA-authorized products
200+ clinical studies across 73,000 sites and more than 675,000 patients

The company fosters a culture of professional growth, diversity, inclusion, and continuous innovation.

Additional Information

This job description outlines primary responsibilities but does not represent an exhaustive list. Syneos Health may assign additional duties based on operational needs. Equivalent experience and education may be considered. The organization adheres to federal, state, and international regulations, including ADA compliance and reasonable accommodation provisions.

Core Functional Focus

Ensuring GCP, protocol, and regulatory compliance during all monitoring phases
Evaluating site performance and recommending corrective actions
Conducting source data verification, query management, and data integrity checks
Overseeing investigational product management and EDC compliance
Maintaining ISF and TMF accuracy and reconciliation
Preparing high-quality monitoring documentation
Serving as the primary point of contact for site-level coordination
Supervising and mentoring junior CRAs as required

How to Apply

Interested applicants may submit their application directly through the Syneos Health careers portal.

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Job Description

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