Job Summary

Provides technical and subject-matter guidance on research regulatory matters. Coordinates completion and timely submission, tracking and communication of research regulatory documents including initial and continuing IRB reviews. Reviews submitted documents for completeness and accuracy. Updates regulatory databases and files repeatedly and without delay. Tracks and communicates compliance of research team members with research training requirements such as CITI Training.

Job Specific Duties

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  Serve as a subject-matter expert on relevant laws, regulations and best practices.
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  Organizes, completes, signs, scans and submits to WCG initial study forms, changes to research, annual and interim reviews, closure reports, administrative documents, deviations/violations, and safety reports as required.
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  Communicates without delay with relevant parties (Investigator and the Clinical Research Coordinator) on research regulatory matters including submissions of initial and continuing review and of changes to research to WCG.
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  Reviews documents received to ensure completeness, accuracy and acquires signatures in a timely manner.
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  Files, scans into, and/or maintains documents in their correct files promptly.
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  Maintains the CITI Training Certification database, Investigators’ Curriculum Vite (CV) and Medical License folders and inputs/updates regulatory fields in MS_H/Drive without delay.
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  Reviews Informed Consents Forms (ICFs) received from Nurses, Residents and Fellows to ensure completeness and conformity to NCH standards.
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  Attends and participates in Research Staff, and Regulatory Affairs meetings.
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  Assists with Research Volunteer process in supplying the necessary information and communication with institutional Research Volunteer office.
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  Assists with developing and delivering research regulatory-related training.
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  Collects and maintains data on regulatory matters as required.

Minimum Job Requirements

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  2-4 years of experience in clinical research

Knowledge, Skills, and Abilities

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  BA/BS in Nursing, Sciences or Education preferred.
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  Certification from ACRP, SOCRA or Health Care Research preferred.
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  Knowledge of rules and regulations governing research.
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  Ability to relate cooperatively and constructively with coworkers, investigators and research staff.
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  Ability to maintain confidentiality of sensitive information.
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  Ability to respond calmly in stressful situations.
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  Ability to use logical thinking to interpret technical data rules and policies and solve regulatory problems.
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  Experience with software applications including word processing, scheduling and contact database, email, web browsing, and other database software.
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  Excellent communication skills.
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  Excellent time management skills.
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  Excellent organizational skills, detail-oriented, people-oriented, flexible and adaptable to change.