Clinical Research Quality & Regulatory Specialist - Rockefeller Neuroscience Institute

West Virginia University • West Virginia, WV

6d

About The Position

The Clinical Research Quality & Regulatory Specialist is responsible for regulatory management of all protocols and ensuring compliance with IRB policies and applicable regulations. The role functions as a project quality manager, liaising with other functional groups and collaborating with the Director of Operations on clinical research quality control from project proposal and IRB approval through study conduct, data analysis, and closeout. The specialist develops research protocols, data and trial management plans, and standard operating procedures for research personnel.

The position provides administrative, quality, and regulatory management for multiple protocols and projects in a dynamic environment. It prepares initial IRB submissions and amendments, including protocol statements, abstracts, consent and assent forms, and discussion materials; prepares and maintains submissions to regulatory bodies over the study lifecycle, including IND and IDE submissions; and serves as a liaison among the principal investigator, IRB, sponsor, research team, and participants. The specialist also supports participant screening, enrollment, and scheduling; research documentation and source records; adverse experience reporting; patient databases and outcomes reporting; research education and staff onboarding; project reports and meetings; and coordination with EPIC systems analysts and third-party software developers to maintain vendor interfaces and resolve issues.

The Rockefeller Neuroscience Institute is a multidisciplinary patient care, education, and research institute within West Virginia University. Its team works with academic, government, and industry partners to advance neuroscience, brain health, and therapeutics. The role is based in the institute's research and clinical environment.

Requirements

• Bachelor's degree in a health-related field.
• At least two years of combined experience in program coordination and clinical experience.
• Equivalent combinations of related education and experience will be considered.
• Maintain skills in, or knowledge of, internal funding mechanisms such as pilot grants.
• Excellent oral and written English language skills.
• Strong organizational skills.
• Ability to read and interpret documents.
• Ability to present information and respond to questions from groups or individuals.
• Ability to create clear, concise paper and electronic documents.
• Ability to work in a multidisciplinary team and coordinate participation of team members from varied backgrounds.
• Group facilitation, mediation, and conflict resolution skills.
• Skill in organizing resources and establishing priorities.

Nice To Haves

• Demonstrated project management experience, with exceptional organizational and time management skills.
• At least five years of clinical experience.

Responsibilities

• Function as a project quality manager and liaise with other functional groups, including data and imaging.
• Collaborate with the Director of Operations to manage clinical research quality control from proposal and IRB approval through study conduct, data analysis, and closeout.
• Develop research protocols, data management plans, trial management plans, and standard operating procedures for research personnel.
• Ensure administrative, quality, and regulatory management of protocols in compliance with IRB requirements, Good Clinical Practice guidelines, and the Code of Federal Regulations.
• Prepare initial IRB submissions and ongoing amendments, including protocol statements, abstracts, consent and assent forms, and discussion materials.
• Prepare and maintain submissions to regulatory bodies throughout the study lifecycle, including IND and IDE submissions.
• Prepare reports and serve as a liaison among the principal investigator, IRB, sponsor, research team, and participants.
• Manage multiple projects and protocols concurrently.
• Prepare, monitor, validate, and maintain research documentation.
• Screen, enroll, and schedule research subjects to support compliance with research protocols.
• Assist with data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.
• Assist with implementation, system administration, and maintenance of patient databases, including collection, analysis, and reporting of patient outcomes data.
• Provide education and training related to RNI research activities and assist with support, training, and onboarding of new research staff.
• Participate in writing project status and results reports and other documentation.
• Arrange and attend meetings, seminars, symposia, and other events related to project efforts.
• Work with EPIC systems analysts and third-party software developers to maintain vendor interfaces and communicate and resolve issues.

Benefits

• 37.5-hour work week.
• 13 paid holidays.
• 24 annual leave (vacation) days per year.
• 18 sick days per year, including leave for illness, family care, and regularly scheduled medical appointments.
• Health insurance and other benefits.
• 401(a) retirement savings with a 6% employee contribution match.
• Eligibility to continue health insurance in retirement and other retiree perks.
• Wellness programs.

What This Job Offers

• Job Type: Full-time