Job Summary
The Clinical Research Associate (CRA) plays a crucial role in the management and monitoring of clinical trials. This position involves ensuring that the trials are conducted in compliance with regulatory requirements and the study protocol. The CRA will collaborate with various stakeholders, including sponsors and research sites, to facilitate efficient study execution and data integrity.
Responsibilities
- Oversee the progress of clinical trials and ensure adherence to protocol and timelines.
- Conduct on-site monitoring visits to verify that data is accurate and protocols are being followed.
- Maintain comprehensive documentation related to study activities including source documents and regulatory binders.
- Develop and maintain relationships with study site staff and address any issues that arise during the trial.
- Assist in the training of site personnel and educate them on study requirements and procedures.
- Collaborate with cross-functional teams to support the overall project goals and timelines.
- Ensure compliance with applicable regulations, guidelines, and study protocols.
Qualifications
- A bachelor’s degree in Life Sciences or a related field is typically required.
- Previous experience in clinical research or as a Clinical Research Coordinator is preferred.
- Strong understanding of Good Clinical Practice (GCP) and regulatory standards.
- Excellent organizational and communication skills, with an ability to work independently and as part of a team.
- Willingness to travel to clinical sites as necessary.
