Sr. In-House CRA

Sr. In-House CRA Be Part of One Team, One Purpose. At Emmes Group , we’re shaping the future of clinical research— where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence , we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units— Emmes, a full-service CRO , and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation , ensuring that every challenge is met with perseverance and accountability. The Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

• Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
• Possesses working knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
• Has solid knowledge of Good Clinical Practices and country regulatory requirements.
• Independently collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Performs upload of essential documents into the trial master file.
• Independently communicates and coordinates effectively with internal project staff members and site staff.
• Independently completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.