Clinical Research Associate Job at Establishment Labs (Houston)

Job Responsibility

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 products 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 studyrelated risks and operational challenges
Participate in continuous improvement initiatives related to clinical processes

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.)