Regulatory Specialist I

Silver Spring, Maryland-Silver Spring
Oct 30, 2020
Dec 04, 2020
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 and provide assessment of the adequacy of human subjects' protections in a research submission. Communicates IRB decisions and rationale for decisions to investigators


Minimum Education
Bachelor's Degree
Master's Degree

Minimum Work Experience
1 year

Specific Requirements and Preferences
A minimum of 1 year of experience in an administrative or regulatory environment to allow for interpretation and application of regulations.A related master's degree may offset required years of experience on a 1:1 basis, e.g., a 1 or 2 year master's degree in lieu of 1 or 2 years of experience. (Required)
Some experience in a human research protections program preferred (Preferred)

Required Skills/Knowledge
Demonstrated oral communication skills sufficient to convey information in a clear concise way, synthesizing information and presenting it to others. Demonstrated ability to edit and write clear, precise, and grammatically correct letters, memos and reports. All preliminary reviews take place in a timely manner so investigator is notified of action items at the earliest possible time to prevent delays in protocol review and approval by the Chair.
Able to work both independently and in a team-oriented environment, follow through on assignments with minimal direction and to independently prioritize work. Able to perform against deadlines with frequent interruptions and competing priorities. Demonstrate ability to edit and write clear, precise, and grammatically correct letters, memos and reports. Communicate sufficiently to convey information in a clear concise way, synthesize information and present it to others.

Functional Accountabilities

Initial Triage of new Incoming Protocols
1. RSI conduct pre-review and triage for research protocols for exempt, expedited and regular review processes.
2. Determine when protocols require special attention due to their complexity and sensitivity. Once this determination is made, notify Manager so the proposal can be advanced for specialized review by a RS-II -RS-IV.

Minimal Risk Regulatory Pre-Review
1. RSI provide review of new protocols involving both clinical and behavioral studies to resolve administrative and technical problems.
2. Ensure compliance with federal, state and Institutional Standard Operating Procedures.
3. Provide professional service to IRB Chairs, IRB Committee members, and research personnel to improve and correct submissions following established principles, theories, and concepts.
4. Provide research personnel with appropriate source documentation and other educational materials to support IRB decisions and facilitate the ethical conduct of research.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification

1. Anticipate and responds to customer needs; follows up until needs are met


1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

1. Use resources efficiently
2. Search for less costly ways of doing things


1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System 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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