Job Summary
The Clinical Research Associate (CRA) plays a pivotal role in managing clinical trials to ensure they are conducted in compliance with regulatory requirements and company standards. This position is integral for monitoring and overseeing clinical studies, supporting the development of new drugs and therapies by coordinating with various stakeholders throughout the process.
Responsibilities
- Oversee and manage the execution of clinical trials from initiation to conclusion.
- Ensure compliance with Good Clinical Practice (GCP) and pertinent local regulations.
- Conduct site visits to monitor study progress and maintain study integrity.
- Review and verify data integrity from clinical study reports.
- Facilitate communication between the study sites, sponsors, and other involved parties.
- Train and guide site staff on study protocols and procedures.
- Assist in the development of study protocols, investigator brochures, and informed consent forms.
- Prepare and maintain comprehensive study files and documentation.
Qualifications
- Bachelor’s degree in a life sciences field or related discipline.
- Prior experience as a Clinical Research Associate or in a related function.
- Strong knowledge of GCP guidelines and regulatory requirements.
- Excellent organizational and communication skills.
- Ability to work independently and collaboratively within a team.
- Proficiency in using clinical trial management software.
Globus Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
