[Remote] In-House Clinical Research Associate

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 advancements in healthcare through innovative technology. They are seeking an In-House Clinical Research Associate responsible for supporting site management and monitoring of clinical trials, ensuring compliance with protocols and regulatory requirements.ResponsibilitiesUnder the supervision of the project site management staff oversight lead i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etcPossesses 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, etcKnowledge of Good Clinical Practices and country regulatory requirementsCollects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirementsUpload essential documents into the trial master fileCommunicates and coordinates effectively with internal project staff members and site staffAssists project teams with trial progress tracking by updating the Clinical Trial Management System and other software toolsMay assist in audit preparation activities as neededMay assist the CRA in Issue and Action Item AI resolution post visit and assists with tracking AIs to completionTracks site trainingMay assist with feasibility and site activation processes in collaboration with clinical operations counterpartsMay assist in preparing study documentsMay assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depotsMay track site recruitment efforts and collect review site screening logsMay assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepanciesMay 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 visitsPerforms other duties as assignedComplies with all policies and standardsSkillsBachelor's Degree Scientific discipline RequiredProficient with MS Office Suite HighGood computer and organizational skills HighHigh attention to detail required HighAbility to work on varying projects and exercise critical thinking HighSelf starter and a team player who can work cross functionally with heavy oversight HighProficient in organizational, interpersonal, and communication skills both oral and written HighDemonstrated problem solving skills, self motivated, and adaptable to a dynamic environment HighKnowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities HighAbility to collaborate with internal and external colleagues and work well in a team oriented setting HighLess than 1 year Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) PreferredCompany OverviewThe 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.