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 an Accreditation Lead to support all phases of clinical trials. Primary Responsibilities
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Oversee and coordinate HRPP activities across the various offices and staff that have roles in protecting research participants
Provide guidance regarding the interpretation of regulations, laws, and policies to the organization's IRBs, researchers staff, and administrators
Ensure that the human research protection training is available and completed by investigators, key study personnel and all staff who participate in the human subjects protection program with the SOPs.
Maintains documentation required by corporate and project SOPs
Detailed working knowledge of accreditation standards
Ensure implementation of corrective action, as needed in accordance with Emmes policies and IRB policies and procedures
Demonstrates understanding of project and corporate SOPs by producing work in compliance
Master degree in a health related field preferred and at least 5 years of IRB experience required
Working knowledge of HRPP accreditation required
Experience in a medical/biologic, or other health-related or clinical research field preferred
Ability to write scientific minutes
Excellent verbal and written communication skills
Strong computer skills
Strong skills in prioritization, problem solving, organization, decision-making, time management and planning
Excellent analytical skills
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EMMES is proud to be an Equal Opportunity Employer EOE/M/F/D/V