Clinical Research Associate

This is a fully remote position, open to applicants in Texas.

📋 Description

• Coordinate and manage clinical trial activities across the entire study lifecycle.

• Offer strategic direction and oversight, mentor junior team members, and liaise with management.

• Create and uphold clinical trial documentation.

• Provide advanced clinical support, including the creation of documents for product registration and the statistical analysis of clinical trials.

• Develop, implement, and manage methods and procedures to improve operational efficiency as necessary.

• Supply clinical insights and expertise to Regulatory Affairs for the preparation of documents needed for product registration and technical files (Clinical Evaluation Report).

• Supervise clinical trial operations and monitor site performance.

• Generate clinical trial reports.

• Ensure submission packages are prepared for Ethics Committees' approval, which includes clinical protocols, case report forms, patient and investigator brochures, informed consent forms, and others.

• Confirm that data entered into the CRFs corresponds with patient clinical notes, known as source data/document verification, by collecting completed CRF forms.

• Assist in the review of statistical plans for clinical trials.

• Stay updated on any changes regarding ethical considerations, scientific principles, legislation, and regulatory guidelines, as well as the clinical evaluation process.

• Identify and communicate any study-related risks and operational challenges.

• Engage 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.

• Certification in Good Clinical Practices.

• Proficiency in systematic literature search tools such as Zotero or Mendeley.

• Knowledge of Medical Device Regulation.

• Advanced English proficiency (C1 level).

• A minimum of 7 years of experience in similar roles.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Planner, etc.).

• This position requires occasional travel within the United States and other regions. A valid passport and full travel availability are mandatory.

🏝️ Benefits

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.