[Remote] In-House Clinical Research Associate- Government

Note The job is a remote job and is open to candidates in USA. Emmes Group is a leading organization in clinical research, focusing on innovative advancements in healthcare. They are seeking an In-House Clinical Research Associate to support the management and monitoring of clinical trials, ensuring compliance with protocols and regulatory requirements.

Responsibilities

Under the supervision of the project site management staff oversight lead i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc Possesses basic 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 Knowledge of Good Clinical Practices and country regulatory requirements 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 Uploads essential documents into the trial master file Communicates and coordinates effectively with internal project staff members and site staff Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools May assist in audit preparation activities as needed May assist the CRA in Issue and Action Item AI resolution post visit and assists with tracking AIs to completion Tracks site training May assist with feasibility and site activation processes in collaboration with clinical operations counterparts May assist in preparing study documents May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots May track site recruitment efforts and collect review site screening logs May assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepancies May assist on site CRA in the conduct of remote and or on site monitoring visits such as site initiation visits, interim routine monitoring visits and closeout visits Performs other duties as assigned Complies with all policies and standards Skills Bachelor's Degree Scientific discipline Required Proficient with MS Office Suite High Good computer and organizational skills High High attention to detail required High Ability to work on varying projects and exercise critical thinking High Self starter and a team player who can work cross functionally with heavy oversight High Proficient in organizational, interpersonal, and communication skills both oral and written High Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High Ability to collaborate with internal and external colleagues and work well in a team oriented setting High Less than 1 year Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) Preferred Company Overview The Emmes Group is where human intelligence meets artificial intelligence. It was founded in 1977, and is headquartered in Rockville, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https//theemmesgroup.com.