Senior Clinical Research Associate - Southwest

3-4 years

$105K-$128K / yr. (est.)

San Mateo

10 March 3, 2025

Job Description

Job Type: Full Time Education: BS/BA 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 - Southwest

Location: San Mateo, CA (Covering Southwest locations: Arizona, New Mexico, Texas, and Louisiana)
Salary Range: $105K - $128K per year (Estimated)
Employment Type: Full-time

Job Summary:

The Senior Clinical Research Associate (SCRA) is responsible for site monitoring, management, and oversight of assigned clinical study sites to ensure data quality and patient safety. This role requires adherence to ICH-GCP guidelines, local regulations, and SOPs while collaborating with Clinical Study Teams (CSTs) to support study activities, mentor junior CRAs, and drive process improvements.

Key Responsibilities:

Conduct and coordinate clinical monitoring activities per GCPs and SOPs.
Perform site visits to ensure protocol and regulatory compliance.
Develop strong collaborative relationships with study sites and vendors.
Track enrollment and study-specific status reports to maintain progress.
Serve as a mentor/trainer for junior CRAs on monitoring procedures.
Assist the Clinical Study Manager with monitoring visit report review and other managerial tasks.
Develop study-specific monitoring tools for data review.
Perform Serious Adverse Event (SAE) reconciliation and resolve discrepancies.
Work with CTOMs and CSTs to manage site trends and ongoing risk assessments.
Ensure study milestone completion (e.g., startup, recruitment, closeout).
Support audit/inspection preparation and resolution of findings.
Provide guidance and support for junior clinical staff as needed.

Supervisory Responsibilities:

Oversee site-level management within established protocols.
Mentor and train junior CRAs.
Identify development opportunities and provide necessary training.
Conduct co-monitoring visits as needed.

Qualifications:

BS/BA in a relevant scientific discipline.
4-6 years of Clinical Operations experience with 3-4 years of CRA monitoring experience in pharma or CRO industry.
Strong knowledge of ICH guidelines and regulatory processes.
Experience in global oncology trials preferred.
Excellent communication, interpersonal, and organizational skills.
Proficiency in Microsoft Office and familiarity with CTMS/data management systems.
Ability to travel 40-60% of the time.

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Senior Clinical Research Associate - Southwest

Job Description

Job Summary:

Key Responsibilities:

Supervisory Responsibilities:

Qualifications:

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