Job Summary
The Home-Based Experienced Clinical Research Associate (CRA) plays a vital role in the successful execution of clinical trials. This position involves working remotely while maintaining a strong focus on project management within clinical settings, ensuring that studies are conducted according to regulatory guidelines and standards. The CRA will be a key liaison between sponsors, site staff, and other stakeholders, contributing to the oversight of clinical trial sites.
Responsibilities
- Manage and monitor clinical trials from initiation through to completion.
- Conduct site assessments, initiation visits, and monitoring visits.
- Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Review and verify clinical data for accuracy and completeness.
- Coordinate site communication and act as a point of contact for query resolution.
- Prepare and submit reports on trial progress and any issues encountered.
Qualifications
- Bachelor’s degree in life sciences, nursing, or related field.
- Proven experience in clinical monitoring or as a CRA in a similar environment.
- Strong knowledge of GCP, ICH, and regulatory guidelines.
- Excellent organizational and communication skills.
- Ability to work independently and manage multiple projects effectively.
- Proficiency in using electronic data capture and clinical trial management systems.
