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  • Date Posted:

    07/25/14
  • Career Level:

    Experienced (Non-Manager)
  • Job Function:

    Healthcare - Other
  • Job Status:

    Full-Time
  • Industry:

    Research, Biotech, Pharmaceutical
  • Contact Information:

    Employer Site
 
 
 
 
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In-House CRA

EMMES Corporation - Rockville, MD

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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


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



*For immediate consideration please submit your resume and apply directly through the company website at www.emmes.com.



Please visit our website at www.emmes.com for more information about our company, studies, and history.



CONNECT WITH US!!
Follow us on Twitter - @EMMESCorp
Find us on LinkedIn - The EMMES Corporation


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




Apply Now
 
 
 
Company Profile

EMMES Corporation

Total Employees: 350
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland, just outside of Washington, D.C., a short distance from NIH, FDA, and the Route I-270 biotechnology corridor. 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 employs a full-time staff of over 350 people. Half of our employees hold advanced degrees. One-third of that group have the highest degree awarded in their fields, typically a Ph.D. or M.D. The balance holds M.P.H., M.S., or M.S.N. degrees. The largest number of advanced degrees are in the areas of statistics, epidemiology, and in the biomedical and health related fields of cell and molecular biology, physiology, biophysics, genetics, cell and developmental biology, pharmacology, microbiology, nutrition, and psychology. Almost all of our employees hold at least a B.S. or B.A. degree in the natural or physical sciences, engineering, computer science, or business administration. Our staff includes individuals who are multi-lingual in German, Russian, Farsi, French, Greek, Spanish, Portuguese, Italian and several dialects of Chinese and Indian languages.
Apply Now
 
 
 
 

Didn't find what you were looking for?

Keywords

Location

  • Date Posted:

    07/25/14
  • Career Level:

    Experienced (Non-Manager)
  • Job Function:

    Healthcare - Other
  • Job Status:

    Full-Time
  • Industry:

    Research, Biotech, Pharmaceutical
  • Contact Information:

    Employer Site
 
 
 
 
16
more jobs from this company
 
 
WPNI ID: 32158392