Clinical Research Associate

🔥 7 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Establishment Labs

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2012

🧬 Biotechnology

Medical Devices • Biotechnology • Healthcare

Establishment Labs is a global medical technology company committed to advancing women's health and wellness through innovative Femtech solutions. Specializing in breast health, aesthetics, and reconstruction, the company offers groundbreaking products like Motiva SmoothSilk breast implants and the Motiva Flora tissue expander. Their technologies are underpinned by scientific research and supported by an extensive portfolio of over 200 patent applications and numerous publications. Establishment Labs aims to normalize and democratize breast health through science-based innovations and evidence-based safety, striving to make a positive social, environmental, and economic impact with their solutions.

📋 Description

• 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

• 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

• Paid time off • Flexible work arrangements • Professional development opportunities