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Children's National Hospital · 1 day ago

Regulatory Specialist III

Washington, DC

Full-time

Onsite

Mid Level

$59K/yr - $59K/yr

3+ years exp

Children's National Hospital is a leading healthcare institution dedicated to providing excellent care for children. The Regulatory Specialist III plays a crucial role in supporting the Institutional Animal Care and Use Committee (IACUC) by managing research protocol review processes and ensuring compliance with regulations.

AssociationChild CareHealth CareNon Profit

Responsibilities

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

Coordinates, monitors and provides regulatory compliance assistance to the Children’s National Institutional Animal Care and Use Committee (IACIC) and/or IACUC 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 IACUC review in accordance with federal and institutional codes, rules and regulations

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

Provides professional service to the IACUC Chair, IACUC Committee and principle investigators

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

Acts as a resource for IACUC members regarding regulations and Children’s National policies and procedures regarding research animals

Composes summaries of the IACUC Committee’s technical deliberations and generates minutes for meetings

Generates correspondence within three days of IACUC meetings for review by manager and IACUC Chair

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 documents

Generates all IACUC-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

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

Demonstrate collaborative and respectful behavior

Partner with all team members to achieve goals

Receptive to others’ ideas and opinions

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

Use resources efficiently

Search for less costly ways of doing things

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

Qualification

IACUC experienceResearch compliance knowledgeRegulatory analysisProblem-solving skillsCommunication skillsInterpersonal skillsOrganizational skillsTime managementLeadership skillsWritten communication

Required

Bachelor's Degree 3-5 years of experience working in an IACUC/research compliance office with increasing IACUC-related responsibilities beyond entry level accepted in lieu of bachelor's degree

Three to five years experience working in an IACUC/Research compliance office with increasing IACUC related responsibilities beyond entry level in lieu of bachelor's degree

Three years of research-related experience, preferably as an IACUC or IRB administrator, using critical thinking, reasoning, problem solving and communication skills

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 research animal subjects and ensuring the institution maintains and tracks documents in a comprehensive and time-sensitive manner