| Research Programs (IRB/IACUC) Coordinator -- Boston, MA |
Author: Leigh Read
Date: 06-11-10 11:50
Joslin Diabetes Center, Inc., Boston, MA
The Research Programs (IRB/IACUC) Coordinator (under the supervision/direction of the Senior Research Programs Administrator) provides support for the day-to-day operations of the Joslin’s IRB and IACUC. Ensures that the IRB and IACUC programs of the Joslin adhere to federal, state, and local regulations as well as institutional policy.
Responsibilities:
*Maintains official records of the IRB and IACUC activities.
*Coordinates IRB and IACUC meetings including the preparation of meeting materials (including agendas and minutes)
*Attends IRB and IACUC meetings to ensure quorum and records deliberations in order to draft minutes and written follow up reports and correspondence.
*Drafts appropriate correspondence to Investigators including decisions of the IRB and IACUC
*Serves as a resource to the research community; answering researchers’ questions about the preparation and submission of new studies and applications of institutional policies and procedures
*Reviews consent forms for protocol and amendment-specific content and to ensure presence of federally mandated elements of informed consent
*Communicates to Investigators items that require clarification or documents required for submission to complete a research application for IRB and IACUC review
*Assists in the development, implementation and maintenance of the IRB and IACUC, including but not limited to SOPs, educational/training materials, associated forms and policies.
*Conducts pre-review of research protocol submission and amendments, for regulatory and institutional compliance to maintain the appropriate governmental compliance.
*Substantively interprets federal and state regulations when conducting a pre-review of the research project.
*Applies appropriate regulations and regulatory requirements by analyzing the unique fact patterns of each submission to assign the regulatory risk determinations based on the research plan, study phase and methodology. Determines the review category, per DHHS/OLAW/NIH/FDA regulations.
*Participates in compliance audits.
Qualifications:
*Bachelor’s degree preferred in related field or equivalent work experience
*3 years administrative experience preferably working with IRB and/or IACUC or within a research setting with a strong preference for prior human subject research experience
*Certified IRB Professional or eligible for certification preferred
*Outstanding written and oral communication skills
*Ability to perform multiple tasks with a high level of accuracy and attention to detail
*Working knowledge of research and medical terminology
*Ability to work independently in a team-oriented environment
*Ability to perform well against deadlines with competing priorities
*Ability to exercise sound judgment and initiative in collecting technical information from a wide variety of sources
*Maintain confidentiality with tact and discretion and be able to interpret and apply ethical principles to his/her daily work
Apply on-line for this position at http://jobs-joslin.icims.com/jobs/2012/login
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