Data Manager/Protocol Monitor (International)

Location
Rockville, MD
Posted
Oct 24, 2017
Closes
Nov 01, 2017
Function
Management
Industry
Science
Hours
Full Time
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Frederick and 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.

Position: This role involves support for a project with international sites currently in India, Sub Saharan Africa, and Latin America. A Data Manager/Protocol Monitor (DM/PM) on this project would typically be responsible for the following:

Primary Responsibilities

    Coordinate site selection and site initiation activities for international sites Determine data collection requirements for new protocols Design source documents Design, build, and implement electronic case report forms (eCRFS) Test and validate eCRFs Moderate conference calls Develop, generate, and distribute data queries and reports to clinical sites Assist in the design and validation of data reports and data quality monitoring resources Contribute to the quality and accuracy of clinical study reports Serve as the primary contact for a subset of clinical sites Train clinic and laboratory personnel on the electronic data capture system Write forms instructions, memoranda, and other study documents Conduct study initiation and interim study visits Remote source document review Prepare and distribute clinical monitoring reports Review and evaluate site corrective action plans submitted in response to the clinical monitoring reports Assist with clinical study drug procurement and importation to clinical sites Document workflow for assigned tasks
Requirements

    Bachelor’s degree in a scientific discipline or equivalent experience Training in and demonstrated understanding of the regulatory obligations of the clinical site monitor; ACRP CCRA certification desirable Strong data management/computer aptitude; experience with CRF design, EDC systems and other web-based data collection systems desired Skills in prioritization, problem-solving, organization, decision-making, time management and planning Excellent oral, written and interpersonal communication skills Self-motivated and detail-oriented Ability to work independently, as well as in a complex team environment Travel to Latin America and Sub Saharan Africa up to 30% Experience in clinical research, specifically infectious diseases and oncology preferred Fluent Spanish or Portuguese preferred

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