CIRB Document Control Specialist

7 days left

Location
Rockville, MD
Posted
Sep 22, 2017
Closes
Sep 30, 2017
Function
Other
Industry
Science
Hours
Full Time
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 EMMES is seeking a CIRB Document Control Specialist to handle administrative tasks related to operating three IRBs.

The Central IRB (CIRB) Initiative- http://www.ncicirb.org/

The Central IRB (CIRB) Initiative is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB use of the CIRB facilitated a review mechanism enables an investigator to enroll patients into adult and pediatric Cooperative Group clinical trials significantly faster than when employing traditional method of IRB review. The CIRB Initiative is sponsored by NCI in consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP).

Primary Responsibilities

  • 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;
  • Schedule continuing review of studies;
  • Distribute Continuing Review reminder notices;
  • Process expedited continuing reviews
  • Maintain a record of all documents posted;
  • Distribute review materials and education materials to Board members as part of regular CIRB meetings as well as for once annual Education Day;
  • Upload files and data into regulatory file database, as needed and requested;
  • Provide administrative and logistical support during convened CIRB meetings;
  • Assist with additional tasks as needed.
Primary Requirements

  • Excellent time management skills, prioritizing, problem solving, organization, decision-making, and multi-tasking
  • 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

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

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