[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

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