Job Summary
The Senior Clinical Research Associate (CRA) plays a pivotal role in ensuring the successful execution of clinical trials from their initiation through to completion. This position entails working remotely while collaborating with cross-functional teams to uphold compliance with regulatory standards and quality assurance throughout the clinical research process. The Senior CRA is expected to lead site management activities, including monitoring progress, managing relationships with sites, and ensuring adherence to protocols.
Responsibilities
- Oversee and manage all aspects of clinical trial sites, including site selection, initiation, monitoring, and close-out activities.
- Ensure compliance with the study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
- Provide training and support to site staff on study protocols and procedures.
- Conduct regular site visits to monitor progress, patient recruitment, and data collection, while resolving any issues that arise.
- Review and verify site documentation, ensuring accuracy and completeness of regulatory compliance.
- Foster strong working relationships with investigators, site staff, and other stakeholders involved in the trials.
Qualifications
- Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
- Significant experience as a Clinical Research Associate, ideally in managing and monitoring clinical trials.
- Strong understanding of GCP and regulatory requirements specific to clinical trials.
- Excellent organizational and communication skills, with a detail-oriented approach.
- Proficiency in using clinical trial management systems and other relevant software tools.
