Summary

We are seeking a qualified, experienced, professional who possesses advanced knowledge of clinical research practices for a full-time position.  This position will function in the clinical research section of the Department of Neurosurgery and Cain Foundation Laboratories.  The personnel will function in a capacity in which they manage, coordinate, and facilitate first-in-human trial program to test various therapies for pediatric epilepsy and related disorders. The personnel will provide administrative, regulatory, and operational support for clinical and translational research studies.  Responsibilities include managing scheduling and personnel activities, coordinating IRB and FDA submissions, assisting in clinical trial agreement processes, and Interfacing with hospital finance for trial costs. The ideal candidate is highly organized, detail-oriented, and experienced in navigating regulatory requirements and cross-functional collaboration within an academic medical center or clinical research environment.

Job Duties

40% Administrative Support

• Coordinate daily administrative activities for the research team, including managing calendars, scheduling meetings, and tracking project deadlines.
• Process purchases for research supplies and services, as well as travel requests and reimbursement paperwork.
• Assist with personnel-related activities, including onboarding, hiring documentation, and maintaining employee records.
• Prepare letters, reports, meeting materials, and other routine documents. Maintain organized research files and records.
• Serve as a point of contact for investigators, staff, and collaborators by responding to questions and coordinating communications.

40% Regulatory Support

• Prepare and submit IRB applications, amendments, continuing reviews, and study closures for human research studies.
• Coordinate required approvals with institutional and hospital offices before studies begin and throughout the life of the project.
• Assist with FDA submissions, including Investigational Device Exemption (IDE) applications, amendments, and annual renewals, when applicable.
• Maintain regulatory files and ensure study documentation is complete and up to date.

20% Contract and Financial Coordination

• Coordinate the clinical trial agreement (CTA) process by working with investigators, sponsors, and institutional contracting offices.
• Work with hospital finance and research administration to support clinical trial budgets, research billing, and study-related financial processes.
• Track contract and regulatory milestones to help ensure studies are activated on schedule.

Scope and Impact

• Provides administrative, regulatory, and operational support.
• Helps ensure research projects remain organized, compliant with institutional and federal requirements, and progress efficiently from study startup through completion.
• Serve as point of contact for investigators, research staff, sponsors, and institutional partners regarding administrative and regulatory matters.
• Develop and improve workflows, standard operating procedures (SOPs), and tracking tools to increase the efficiency of research operations.
• Monitor study and regulatory deadlines to ensure timely completion of required submissions and approvals.
• Assist with preparing documentation for internal reviews, sponsor monitoring visits, and regulatory audits.
• Perform other duties and special projects as assigned to support departmental and institutional research objectives.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Knowledge and experience of regulatory aspects of clinical research is a must.
• Effective communication skills, both orally and in writing.
• Ability to understand and implement research studies and protocols.
• Interpersonal skills necessary to coordinate research studies.