Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the management and oversight of clinical trials to ensure compliance with regulatory standards and study protocols. This position requires attention to detail and a thorough understanding of clinical research processes, as well as communication and coordination with various stakeholders involved in clinical studies.
Responsibilities
- Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and study protocols.
- Assist in the selection and initiation of clinical study sites.
- Conduct routine site visits, provide training to site personnel, and ensure the accuracy of data collection.
- Collaborate with cross-functional teams to facilitate the smooth execution of clinical trials.
- Review site performance and resolve any issues that may arise during the course of the study.
- Prepare and maintain accurate documentation related to site visits and trial progress.
Qualifications
- Bachelor’s degree in life sciences or a related field.
- Proven experience in clinical research or a similar role is preferred.
- Knowledge of FDA regulations, ICH guidelines, and GCP standards.
- Strong organizational and communication skills.
- Ability to work independently and as part of a team.
- Proficiency in data management and reporting software.
Integrated Resources 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.
