Regulatory Specialist Iii - Fully Remote

The Regulatory Specialist III provides professional support to the Children's National Hospital Institutional Review Board (IRB) by coordinating the daily activities associated with the processing of research protocols and all facets of protocol review management. The RS-III conducts protocol pre-reviews, applies knowledge of human subject protection regulations and institutional policies to manage IRB meetings and provides consultation/education to investigators and research staff. The individual communicates IRB decisions and rationale to investigators.
Qualifications:
Minimum Education
Bachelor's Degree 3-5 years of experience working in an IRB/research compliance office with increasing IRB-related responsibilities beyond entry level and Certified IRB Professional (CIP) accepted in lieu of bachelor's degree. (Required)
Master's Degree (Preferred)
Minimum Work Experience
3 years 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. (Required)
3 years Three years of research-related experience, preferably as an IRB or IACUC administrator, using critical thinking, reasoning, problem solving and communication skills. (Required)
Required Skills/Knowledge
Strong independent judgement related to situations of a sensitive, confidential and scientific nature.
Extensive knowledge of research regulations and scientific/medical terminology, as well as the ability to analyze, comprehend and apply these appropriately to social and behavioral science research.
Ability to maintain balance between ensuring institutional compliance and providing service to investigators.
Excellent problem- solving, interpersonal, organizational, time management and leadership skills.
Ability to use sound judgement and make difficult decisions under pressure.
Strong written and verbal communication skills and ability to use them to communicate effectively.
Strong writing skills.
Ability to perform moderately complex duties to facilitate the review and approval process to include determining the appropriate level of review and interpreting and applying federal and state laws, regulations, institutional policies and guidelines governing biomedical research.
Commitment to protecting human subjects and ensuring the institution maintains and tracks documents in a comprehensive and time-sensitive manner.
Required Licenses and Certifications
CIP (Certified IRB Professional 1 Year (Required)
Functional Accountabilities
Responsible Conduct of Research

• Consistently demonstrates adherence to the standards for the responsible conduct of research.

• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.

• Uses research funds and resources appropriately.

• Maintains confidentiality of data as required.

• Meets all annual job-related training and compliance requirements.

Initial Protocol Triage

• Coordinates, monitors and provides regulatory compliance assistance to the Children's National Institutional Review Board (IRB) and/or IRB Chair.

• Analyzes all protocol submissions for completeness and accuracy, as well as the internal consistency of application materials.

• Possesses knowledge of federal and state research regulations and scientific/medical terminology, as well as ability to analyze and comprehend research.

• Makes recommendations for the appropriate level of IRB review in accordance with federal and institutional codes, rules and regulations.

• Conducts initial review and tracks documents in a comprehensive and time sensitive manner.

Review and Documentation

• Provides professional service to the IRB Chair, IRB Committee and clinical investigators.

• Generates regulatory compliance pre-review and develops meeting agenda, meeting packets and supplemental materials.

• Acts as a resource for IRB members regarding regulations and Children's National policies and procedures regarding human subjects.

• Composes summaries of the IRB Committee's technical deliberations and generates minutes for meetings.

• Generates correspondence within three days of IRB meetings for review by manager and IRB Chair.

Communication

• Responds to all phone calls and emails within 24-48 hours in a timely, efficient and professional manner.

• Provides regulatory and ethical advice to faculty and staff in preparation of protocol applications and consent documents.

• Generates all IRB-related correspondence to principal investigator and verifies the accuracy and timeliness of such.

• Serves as point person for principal investigator requests for pre-review of protocol.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification

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

Teamwork/Communication

• Demonstrate collaborative and respectful behavior

• Partner with all team members to achieve goals

• Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance