About the Role
Our client is seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join their fully remote team, supporting groundbreaking pharmaceutical research. In this vital role, you will be responsible for monitoring clinical trial sites, ensuring compliance with protocols and regulatory standards, and safeguarding the integrity of study data. You will collaborate closely with investigators, site staff, and internal project teams to facilitate the smooth execution of clinical trials aimed at developing new therapies. This position offers the flexibility of a remote work environment coupled with the opportunity to make a significant impact on patient health, working within an organization that values efficiency, accuracy, and ethical conduct in all research endeavors.
Key Responsibilities Conduct site monitoring visits (on-site and remote) to assess trial progress, patient safety, and data accuracy. Ensure compliance with Good Clinical Practice (GCP ) guidelines, FDA regulations, and study protocols. Train and support site staff on study procedures, regulatory requirements, and data collection. Review source documents, case report forms (CRFs), and other study-related data for completeness and accuracy. Identify and resolve site-specific issues and escalate critical findings to study management. Manage communication and documentation between study sites and the sponsor. Requirements Bachelor's degree in a life science, nursing, or related field; advanced degree preferred. Minimum of 3 years of experience as a Clinical Research Associate or equivalent. In-depth knowledge of clinical trial processes , GCP, ICH guidelines, and relevant regulatory requirements. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent organizational, communication, and interpersonal skills. Ability to travel to sites as needed, though this role is primarily remote. Benefits Competitive annual salary commensurate with experience. Comprehensive benefits package including health, dental, and vision insurance. Remote work flexibility, allowing for a healthy work-life balance. Paid time off and company holidays. Professional development opportunities and support for continuing education.