Senior Clinical Research Associate (Cra Iii) - East Coast

5+ years

$110K-$135K / yr. (est.)

San Mateo

10 March 3, 2025

Job Description

Job Type: Full Time Education: BS/B.E./B.tech 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 III) - East Coast

Location: San Mateo, CA
Company: Presidio Medical, Inc.
Salary: $110K - $135K (Estimated)

Job Description:
Presidio Medical is developing advanced neuromodulation technology with an initial focus on treating chronic pain. The Senior Clinical Research Associate (CRA III) will ensure the protection of human subjects’ rights, the accuracy of trial data, and compliance with regulatory requirements, including ISO14155. Reporting to the Study Manager, this role involves oversight of clinical trials, study implementation, and monitoring processes.

Responsibilities:

Ensure completeness of study files.
Assist in developing project and monitoring plans, and communicate timelines to CRAs.
Review protocols, investigator brochures, safety reporting requirements, data collection tools, and study procedures.
Lead development of source worksheets and participant information in alignment with protocol requirements.
Assist in drafting and reviewing Case Report Forms with Data Management.
Monitor and track study implementation and progress.
Prepare internal and external study progress reports.
Facilitate communication flow across the study team and liaise between CRAs and other departments.
Provide study updates in company meetings.
Identify and resolve study-related issues in consultation with the Study Manager.
Lead the CRA team, including mentoring, coordinating monitoring activities, and conducting co-monitoring visits.
Identify and address CRA performance issues.
Support CRA onboarding and participate in investigator and team meetings.
Prepare and review site payment documentation.
Ensure study quality, prepare for audits, and provide feedback on departmental SOPs.
Manage small clinical studies (1-3 sites) independently.

Qualifications:

B.S. or higher degree in Engineering or related fields, or equivalent industry experience.
5+ years of Clinical Research experience, with at least 2 years in medical device clinical trials.
Strong knowledge of ISO14155, ICH GCP, and US FDA CFR/Australian TGA regulations.
Experience in protocol development, clinical study design, and data monitoring.
Demonstrated ability to lead CRA teams and manage clinical trials.
Proficiency in project management and budgeting.
Ability to travel extensively, both internationally and within the US.
Proficiency in clinical trial software systems.

Physical Demands:

Varied sitting, standing, and walking.
Ability to lift and carry up to 50 lbs.

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Senior Clinical Research Associate (Cra Iii) - East Coast

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