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