Senior Clinical Research Associate
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About The Position
Kelly® Science & Clinical is seeking a Senior Clinical Research Associate (CRA) and Manager for a full-time, direct hire position with a pharmaceutical client in New Jersey. This role is pivotal for individuals passionate about translating scientific discoveries into practical applications. The Senior CRA will be responsible for the implementation, monitoring, and summarization of clinical trials, ensuring compliance with protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and Standard Operating Procedures (SOPs) to guarantee patient safety throughout the clinical trial process. In this position, the Senior CRA will serve as the primary liaison for assigned study sites, effectively conveying project information, addressing inquiries, and resolving site-related issues in alignment with the clinical monitoring plan. A thorough understanding of study management tasks and responsibilities is essential to comply with protocol and regulatory requirements. The CRA will attend Investigator Meetings and study-specific training for assigned trials, ensuring comprehensive knowledge of assigned protocols and trial-specific manuals to meet quality and deliverables across all assigned sites. The role involves conducting pre-study qualification visits, site initiation visits, routine monitoring, and close-out visits within established timelines, documenting all activities in accordance with applicable SOPs and plans. Building and maintaining strong collaborative relationships with clinical investigative sites is crucial, as is ensuring the trial site's adequacy and personnel qualifications on an ongoing basis. The Senior CRA will also be responsible for developing and executing corrective action plans at the site level, ensuring data integrity, patient safety, and regulatory compliance for all assigned sites. Monitoring recruitment and data quality, both on-site and remotely, is a key responsibility, along with ongoing data review and source data verification to meet study-specific targets and deadlines.
