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 Regulatory Affairs Specialist for regulatory oversight which includes monitoring for and contributing to the resolution of compliance issues . EMMES is seeking a CIRB Document Control Specialist to handle administrative tasks related to operating three IRBs.
- Provide support to CIRB Coordinators for the management of multiple IRBs
- Provide updates to Monthly Progress Report;
- Post documents to website as requested;
- Draft and distribute letters to institutions;
- Distribute Continuing Review notices as directed;
- Maintain a record of all documents posted;
- Distribute a website posting summary to listserv;
- Distribute review materials and education materials to Board members;
- Upload files and data into regulatory file database, as needed and requested;
- Assist with additional tasks as needed
- Work experience in health related field, preferably including IRB experience
- Strong working knowledge of Microsoft Office
- Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
- High attention to detail is a necessity
- Excellent time management skills, prioritizing, problem solving, organization, decision-making, and multi-tasking
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