Job Summary
The Clinical Research Associate (CRA) plays a pivotal role in managing clinical trials and ensures that studies are conducted in accordance with regulatory standards and protocols. The CRA acts as a liaison between the research site and the sponsor, facilitating the smooth execution of clinical research projects. This position requires a blend of strong organizational skills, attention to detail, and a sound understanding of clinical research processes.
Responsibilities
- Oversee and coordinate the clinical trial process from initiation to completion.
- Monitor trial sites to ensure adherence to regulatory requirements and the study protocol.
- Conduct site visits to evaluate study progress, subject recruitment, and data accuracy.
- Maintain communication with investigators and site staff regarding project-related issues.
- Prepare and review study documentation, including informed consent forms and regulatory submissions.
- Assist in training site staff on study procedures and protocols.
- Provide ongoing support to the project team and report any issues or findings to management.
Qualifications
- A bachelor’s degree in life sciences or a related field is typically required.
- Experience in clinical research or a related field is preferred.
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent organizational and time management skills.
- Effective communication skills, both written and verbal.
- Ability to work independently and as part of a team.
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.
