Clinical Research Associate

Establishment Labs

Clinical Research Associate overseeing clinical investigations at Establishment Labs, a women's health company. Ensuring compliance with international regulations and leading clinical trial operations.

Posted 6/11/2026full-timeRemote • Texas • 🇺🇸 United StatesJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Coordinate and oversee clinical trial activities throughout the study lifecycle.
Provide strategic guidance and oversight, mentoring junior staff and coordinating with management.
Develop and maintain clinical trial documentation.
Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials.
Create, implement and administer methods and procedures to enhance operations, as appropriate.
Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for product registration and technical file (Clinical Evaluation Report).
Oversee clinical trial operations and site performance.
Clinical trials reports creation.
Submission package readiness for Ethics Committees approval; including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others.
Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification, collecting completed CRF forms.
Support and review of statistical plans for clinical trials
Monitor any updates that may arise about ethical considerations, scientific principles, legislation and regulatory guidelines, and clinical evaluation process.
Identify and communicate study-related risks and operational challenges
Participate in continuous improvement initiatives related to clinical processes.

Requirements

What you’ll need

Bachelor’s degree in a relevant field such as life sciences, engineering, pharmacy, business, clinical research, or a related discipline.
Good Clinical Practices certification
Knowledge in Systematic literature search Zotero/Mendeley
Medical Device Regulation
Advanced English C1 scored
7+ years of experience on similar roles
Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.)
This role requires periodic travel in the United States and other regions. A valid passport and full travel availability are essential.

Benefits

Comp & perks

Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementstatistical analysisdocument creationdata verificationclinical protocolscase report formsinformed consent formclinical evaluation reportrisk identificationcontinuous improvement

Soft Skills

strategic guidancementoringcommunicationoversightproblem-solvingcollaborationorganizational skillsattention to detailleadershipadaptability

Certifications

Good Clinical Practices certification