Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the clinical trials process, overseeing the conduct of studies and ensuring compliance with regulations and protocols. This position is vital for the successful execution of clinical research studies, managing various tasks related to site monitoring, data integrity, and overall trial management.
Responsibilities
- Conduct site visits to monitor clinical trials and ensure adherence to study protocols.
- Evaluate and verify the accuracy of data collected from clinical sites.
- Collaborate with clinical study teams to facilitate smooth project execution.
- Assist in preparing study documentation and reports for regulatory submissions.
- Train site staff on trial protocols and Good Clinical Practice (GCP) guidelines.
- Identify, address, and resolve any issues or discrepancies in trial data.
Qualifications
- Bachelor’s degree in a related field, such as life sciences or nursing.
- Prior experience in clinical research or related field preferred.
- Strong understanding of GCP, FDA regulations, and clinical trial processes.
- Excellent organizational and communication skills.
- Capability to work independently as well as part of a team.
- Willingness to travel to monitor clinical sites as necessary.
Opis S.r.l. 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.
