Regulatory Specialist III
Company: Children's National Medical Center
Location: Silver Spring
Posted on: June 5, 2021
Responsible for providing professional support to the Children's
National Medical Center Institutional Review Board (IRB). Conducts
protocol pre-reviews. Applies knowledge of human subject protection
regulations and institutional policies to manage IRB meetings and
provide consultation/education to investigators and research staff.
Communicates IRB decisions and rationale to investigators.
A combination of relevant education and experience may be
substituted as appropriate. (Required)
Minimum Work Experience
Three to five years experience working in an IRB/Research
compliance office with increasing IRB related responsibilities
beyond entry level and CIP (Certified IRB Professional) accepted in
lieu of bachelor's degree. If not currently CIP certified, must be
obtained prior to the end of a 12 month employment term. Minimum 3
years experience in IRB/research administration. Requires three
years of research related experience, preferably as an IRB or IACUC
administrator using critical thinking, reasoning, problem solving
and communication skills. .
Under general direction, coordinates the daily activities
associated with the processing of research protocols and all facets
of protocol review management to assist Institutional Review Boards
(IRB). Position requires considerable exercise of independent
judgment related to situations of a sensitive, confidential and
scientific nature. Applicants must have extensive knowledge of
research regulations, scientific/medical terminology as well as
ability to analyze, comprehend and apply them appropriately to
social and behavioral sciences research. The RS-III must have
ability to maintain balance between ensuring institutional
compliance and providing service to investigators. Applicants must
also have excellent problem-solving, interpersonal, writing and
organizational skills and possess strong leadership skills and the
ability to make difficult decisions under pressure. The IRB
Regulatory Affairs Specialist III will perform moderately complex
duties to facilitate the review and approval process to include
determining the appropriate level of review, interpret and apply
federal and state laws, regulations, institutional policies and
guidelines governing biomedical research; to protect human subjects
and to ensure institution maintaining and tracking documents in a
comprehensive and time-sensitive manner. The IRB Regulatory
Specialist III is primarily responsible for the management of a
caseload of applications submitted for IRB review. In this
capacity, the IRB Regulatory Specialist III must demonstrate sound
judgment, as well as analytical, organizational, and time
management skills. The assigned job responsibilities require a firm
foundation in the guidance and regulations that govern the
inclusion of human subjects in research.
Initial Protocol Triage
Coordinate, monitor, and provide regulatory compliance
assistance to the CNMC Institutional Review Board (IRB) and or IRB
Analyze all protocol submissions for completeness, accuracy; and
internal consistency of the application materials.
Has knowledge of federal and state research regulations and
scientific/medical terminology as well as ability to analyze and
Make recommendations for the appropriate level of IRB review in
accordance with federal and institutional codes, rules, and
- Conduct initial review and track documents in a comprehensive
and time-sensitive manner
IRB Meeting Regulatory Review and Documentation
Provide professional service to the IRB Chair, IRB Committee,
and clinical investigators.
Generate regulatory compliance pre-review; develop meeting
agenda and supplemental materials and meeting packets.
Act as a resource for IRB members regarding regulations and CNMC
policies and procedures regarding human subjects.
Compose summaries of the Committee's technical deliberations and
Generate correspondence from IRB meeting within 3 days of
meeting for review by Manager and IRB Chair.
- Generate all IRB related correspondence to PI and verifying the
accuracy and timeliness of such
Answer all telephone calls and emails in a timely, efficient and
professional manner within 24-48 hours.
IRB Regulatory Specialist II is responsible for accurate and
timely entry of appropriate data into IRB database.
Able to communicate effectively in both written and oral
Provide regulatory and ethical advice to faculty, staff, in
preparation of protocol applications and consent documents.
- Serve as point person for PI requests for pre-review of
Keywords: Children's National Medical Center, Silver Spring , Regulatory Specialist III, Other , Silver Spring, Maryland
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