Sr. In-House CRA
Emmes Group - Rockville, MD
Hiring: Sr. In-House CRA Company: Emmes Group Location: Rockville, MD Job Posted Time: 2026-09-10 11:47:45 Employment Type: Remote Target Skills & Keywords : Microsoft Office, Project Management About the job Experience: •1-3 years of relevant clinical research experience, Required •47 years of scientific excellence •3 years of relevant clinical research experience, Required •Over 47 years of scientific excellence Required Skills: •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. •Provides project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools. Qualifications: •Bachelor's Degree Scientific discipline preferred, or directly applicable work experience preferred Required •Proficient with MS Office Suite High •Excellent computer and organizational skills High •High attention to detail required High •Demonstrated capacity to work on varying projects and exercise critical thinking High self starter who can work independently and a team player who can work cross functionally with limited oversight High •Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required High •Excellent 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 •Demonstrated capacity to collaborate with internal and external colleagues and work well in a team oriented setting High Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!