Job Summary
The Clinical Research Associate (CRA) plays a vital role in managing and overseeing clinical trials to ensure that they are conducted in compliance with regulatory standards. This position involves working closely with various stakeholders to facilitate the accurate reporting and analysis of clinical data while maintaining the integrity of the study. CRAs serve as a key link between the sponsor and the study sites, ensuring that protocols are followed and any arising issues are promptly addressed.
Responsibilities
- Monitor clinical trial sites to ensure adherence to the study protocol and regulatory requirements.
- Collect, verify, and manage data related to the clinical trial activities.
- Facilitate communication between the sponsor, sites, and other stakeholders throughout the trial process.
- Conduct site selection and initiation visits to prepare sites for the trials.
- Identify and mitigate potential issues and risks that may affect trial timelines and outcomes.
- Prepare and maintain reports documenting trial progress and site compliance.
Qualifications
- A degree in life sciences or a related field is typically required.
- Experience in clinical research, especially as a CRA, is highly preferred.
- In-depth knowledge of Good Clinical Practice (GCP) and relevant regulatory guidelines.
- Strong interpersonal and communication skills for effective collaboration with various teams.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
Extremity Care 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.
