Careers at EMMES
A career at EMMES is a commitment to pursuing truth and knowledge in health applications. We offer a climate that encourages personal and intellectual growth while providing job security and stability. Employees can feel confident that the work we do has an impact on human health.
|Position Location:||401 North Washington Street, 7th Floor, Rockville, MD 20850|
|Job Code:||TAL-In-House CRA|
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in
**The position involves some local, day trip monitoring visits with minimal overnights required!!
· 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
· 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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