In-House CRA

Description

The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. EMMES is seeking a permanent In-House Clinical Research Associate to support all phases of clinical trials.

**The position involves some local, day trip monitoring visits with minimal overnights required!!

Primary Responsibilities

·         Possesses detailed knowledge of the study protocol and its associated activities and timelines

·         Participates in the preparation and/or review of draft protocol and informed consent documents

·         Participates in conference calls, prepares agenda and summaries

·         Coordinates with project team and other study personnel to determine data collection requirements based on protocol and to test electronic case report forms

·         Reviews, contributes to, and processes project documents and required reports, such as study protocol documents and consent forms, SAE and protocol deviation reports, accrual and other study status and/or study web site reports

·         Contributes to project-specific site initiation activities, tracks readiness status of sites for study initiation, (e.g., submission of essential documents, writes and distributes corresponding internal reports)

·         Conducts site assessments, including site activation, interim monitoring and close-out visits. Writes and distributes site visit reports within established timelines, and tracks resolution of outstanding issues

·         Collects reviews and maintains regulatory documents. Review includes assessment of completeness and compliance with regulatory requirements

·         Prepares and reviews study and project materials, (e.g., Manual of Operating Procedures (MOPs), User's Guides, Data Management Handbooks, and SOPs)

·         Generates queries, produces and distributes anomaly reports and resolves data discrepancies

·         Coordinates with project statistician to develop and produce project-specific reports

·         Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs

·         Maintains documentation required by corporate and project SOPs

·         Conducts training sessions for site personnel on GCP, study protocol requirements, EMMES data systems and data management practices

·         Participates in internal audits and other project and corporate quality assurance activities, (e.g., participates in Corporate Quality Overview Team (CQOT) meetings)

·         Reviews and contributes to project-required reports (e.g., contract reports)

·         Attends and participates in project and functional area meetings and continuing education

·         Performs data entry as necessary

·         Communicates and coordinates effectively with internal and external clients and colleagues

 Requirements

·         Bachelor's degree in a scientific discipline or equivalent experience

·         Experience in clinical research required

·         Site monitoring experience required

·         Training in and demonstrated understanding of the regulatory obligations of the clinical site monitor; ACRP CCRA or SOCRA CCRP certification desirable

·         Data management/computer aptitude; experience in programming and database applications (e.g., SAS, Access, Excel) desirable

·         Skills in prioritization, problem solving, organization, decision-making, time management, and planning

·         Self-motivated and detail-oriented

·         Excellent oral and written communication skills

·         Ability to work independently, as well as in a complex team environment

EMMES has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs. 

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EMMES is proud to be an Equal Opportunity Employer. EOE/M/F/D/V