Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the field of clinical trials by monitoring and overseeing the progress of research studies in accordance with regulatory requirements, good clinical practices, and study protocols. The individual will serve as a vital link between research sites and the sponsor, ensuring data integrity and compliance throughout the study lifecycle.
Responsibilities
- Conduct site visits to monitor study progress and ensure adherence to the protocol and regulatory guidelines.
- Review trial-related documents and ensure proper documentation is maintained.
- Collaborate with investigators and site staff to provide support and guidance during the study.
- Assess data for accuracy and completeness, resolving any discrepancies as they arise.
- Facilitate training for site personnel on the study protocol and procedures.
- Prepare and submit reports on study progress to the project manager or sponsor.
Qualifications
- Bachelor’s degree in a relevant field such as life sciences, nursing, or a related discipline.
- Experience in clinical research, particularly monitoring, is preferred.
- Strong knowledge of GCP, FDA regulations, and other applicable guidelines.
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects and prioritize tasks effectively.
EPM Scientific 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.
