Regulatory Specialist III

Location
Silver Spring, Maryland-Silver Spring
Posted
Mar 04, 2021
Closes
Apr 08, 2021
Ref
210000LO
Function
Nurse
Industry
Healthcare
Hours
Full Time
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.

Qualifications

Minimum Education
Bachelor's Degree
Master's Degree
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. .

Required Skills/Knowledge
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.

Functional Accountabilities

Initial Protocol Triage
1. Coordinate, monitor, and provide regulatory compliance assistance to the CNMC Institutional Review Board (IRB) and or IRB Chair.
2. Analyze all protocol submissions for completeness, accuracy; and internal consistency of the application materials.
3. Has knowledge of federal and state research regulations and scientific/medical terminology as well as ability to analyze and comprehend research.
4. Make recommendations for the appropriate level of IRB review in accordance with federal and institutional codes, rules, and regulations.
5. Conduct initial review and track documents in a comprehensive and time-sensitive manner

IRB Meeting Regulatory Review and Documentation
1. Provide professional service to the IRB Chair, IRB Committee, and clinical investigators.
2. Generate regulatory compliance pre-review; develop meeting agenda and supplemental materials and meeting packets.
3. Act as a resource for IRB members regarding regulations and CNMC policies and procedures regarding human subjects.
4. Compose summaries of the Committee's technical deliberations and generates minutes.
5. Generate correspondence from IRB meeting within 3 days of meeting for review by Manager and IRB Chair.
6. Generate all IRB related correspondence to PI and verifying the accuracy and timeliness of such

Communications
1. Answer all telephone calls and emails in a timely, efficient and professional manner within 24-48 hours.
2. IRB Regulatory Specialist II is responsible for accurate and timely entry of appropriate data into IRB database.
3. Able to communicate effectively in both written and oral form.
4. Provide regulatory and ethical advice to faculty, staff, in preparation of protocol applications and consent documents.
5. Serve as point person for PI requests for pre-review of protocols.

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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