Sr. In-House Clinical Research Associate- Government

In-House Clinical Research Associate Emmes Group is a leading clinical research organization leveraging over 47 years of scientific excellence to accelerate the development of life‑changing therapies. The In‑House Clinical Research Associate supports site management and monitoring of clinical studies, ensuring compliance with protocols, SOPs, and regulatory requirements. Responsibilities Work under the supervision of project site management staff such as Clinical Trial Manager, Lead CRA, or Clinical Project Manager. Utilize basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff, including enrollment updates, documentation gaps, and meeting arrangements. Apply Good Clinical Practices and relevant country regulatory requirements. Collect, review, maintain, and track essential documents, assessing completeness, accuracy, and regulatory compliance. Upload essential documents into the trial master file. Communicate and coordinate effectively with internal project staff members and site staff. Assist project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools. Assist in audit preparation activities as needed. Support the CRA in issue and action item resolution post‑visit and track AI completion. Track site training. Assist with feasibility and site activation processes in collaboration with clinical operations counterparts. Assist in preparing study documents. Assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots. Track site recruitment efforts and review site screening logs. Assist with database review to assess data currency and resolve data query discrepancies. Support the CRA in remote or on‑site monitoring visits, including site initiation, interim routine, and closeout visits. Perform other duties as assigned. Comply with all policies and standards. Qualifications Bachelor’s Degree in a scientific discipline. Less than one year of previous clinical research experience preferred (CTA, in‑house CRA, study coordinator, etc.). Proficient with MS Office Suite. Strong computer and organizational skills. High attention to detail. Ability to work on varying projects and exercise critical thinking. Self‑starter and team player capable of cross‑functional collaboration with heavy oversight. Proficient in organizational, interpersonal, and communication skills, both oral and written. Demonstrated problem‑solving skills, self‑motivation, and adaptability to a dynamic environment. Knowledgeable in prioritization, decision‑making, time management, and planning activities. Ability to collaborate with internal and external colleagues and work well in a team‑oriented setting. #J-18808-Ljbffr The Emmes Company, LLC