Senior Clinical Research Associate (CRA) jobs in United States
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FemPulse Corporation · 1 day ago

Senior Clinical Research Associate (CRA)

positionSan Francisco Bay Area
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

FemPulse Corporation is a Bay Area based med-tech startup seeking an experienced, detail-oriented and collaborative Senior Clinical Research Associate (Sr. CRA) to support an FDA IDE pivotal clinical trial of a novel, non-implanted neuromodulation device for overactive bladder (OAB) in women. The CRA will bring EDC expertise, medical device monitoring experience, and a supportive approach to help clinical coordinators succeed, with responsibilities including site monitoring and ensuring compliance with regulatory requirements.

Consumer GoodsManufacturing

Responsibilities

Perform site qualification, initiation, interim monitoring, and close-out visits
Ensure compliance with IDE regulations, GCP, IRB requirements, and approved protocol
Verify informed consent, source documentation, and accurate CRF/eCRF completion
Monitor device accountability, investigational product handling, and protocol adherence
Identify, document, and follow up on protocol deviations, AEs, and SAEs
Prepare high-quality monitoring reports and track corrective and preventive actions (CAPAs)
Support inspections and audits; maintain inspection-ready TMF
Contribute to monitoring plans and SOP development as needed
Collaborate with PI, field clinical engineer, and CRO

Qualification

CRA experienceFDA IDE requirementsICH GCPEDC systemsElectronic TMF platformsUrology experienceGynecology experienceNeuromodulation studiesCollaborative approach

Required

Bachelor's degree in life sciences or related field
5+ years of CRA experience, including hands-on monitoring of IDE studies
Strong working knowledge of FDA IDE requirements, 21 CFR 812, and ICH GCP
Experience with EDC systems and electronic TMF platforms (Medrio and Florence preferred)
Ability to travel as required (typically 30-50%)

Preferred

Experience with urology, gynecology and/or neuromodulation studies

Company

FemPulse Corporation

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Overactive bladder (OAB) affects over 15 million women in the US. The sudden, urgent desire to pass urine greatly limits quality of life.
dateFounded in 2011
location
Saint Paul, Minnesota, USA
people-size2-10 employees
web-link
http://www.fempulse.com

Funding

Current Stage
Early Stage

Recent News

GlobeNewswire
FemPulse Positive Clinical Data To Be Presented at SUFU Conference
2026-01-07
GlobeNewswire
Medical AI Expert Wido Menhardt Joins FemPulse Scientific Advisory Board
2026-01-06
Company data provided by crunchbase