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:
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
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
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.
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