Assistant Director of Epilepsy Research Operations

University of Minnesota•Minneapolis, MN

29d•$96,000 - $120,000

About The Position

The Comprehensive Epilepsy Institute within the University of Minnesota Department of Neurology is seeking a Clinical Research Manager to serve as the operational lead for a growing portfolio of federal and industry-sponsored clinical studies in epilepsy. This newly created position will oversee the clinical research infrastructure of the Institute, supervising a team of clinical research coordinators, regulatory specialists, and other study personnel. This role is critical to establishing a high-performing research enterprise through high-quality trial execution, regulatory compliance, and close coordination with investigators, clinical partners, sponsors, and inter-departmental collaborators. This position provides a unique opportunity to help build the research foundation of a world-class epilepsy institute. The Assistant Director will operate with a high level of independence, contribute strategic input, and provide leadership to a growing team. This position reports to the Director of Research for the Department of Neurology and is overseen by the Director of the Comprehensive Epilepsy Institute.

Requirements

BA/BS with at least 6 years of experience, or an advanced degree with 4 years of experience, including prior leadership of a small team or cross-disciplinary research group.
At least 2 years of prior clinical research experience in academic, industry, or healthcare settings.
Demonstrated experience supervising staff, managing complex workflows, and implementing process improvements.
Excellent communication, leadership, and organizational skills.

Nice To Haves

Experience in epilepsy, neurology, neuromodulation, or related CNS clinical research.
Experience managing both industry-sponsored and federally funded clinical trials.
Prior responsibility for IRB submissions, monitoring visits, audits, and regulatory documentation.
Strong project or program management skills, preferably with formal PM training or certification.
Experience with clinical research compliance systems such as OnCore/CTMS, REDCap, or similar platforms.
Experience with project management tools such as Asana or Smartsheet.

Responsibilities

Staff Leadership, Oversight, & Team Development
Provide direct supervision, coaching, performance management, and career development for Clinical Research Coordinators, Regulatory Specialists, and other research staff.
Oversee day-to-day workload assignments, task prioritization, and role clarity across the epilepsy research team.
Ensure regulatory specialists complete all IRB submissions, continuing reviews, modifications, reportable events, and regulatory binders accurately, on time, and in compliance with University, sponsor, and federal policies.
Ensure clinical research coordinators conduct study visits, participant follow-up, recruitment, data collection, and documentation to the highest quality standards.
Establish and enforce operational expectations, SOPs, quality standards, and documentation practices.
Conduct regular team meetings and individual check-ins to support communication, efficiency, and accountability.
Lead recruitment, hiring, onboarding, and training for new staff and forecast future staffing needs.
Foster a collaborative, positive research culture with shared ownership of project goals.
Serve as the primary operational point of contact for investigators, clinical teams, sponsors, CROs, and internal stakeholders regarding staff performance and study execution.
Administrative, Operational, & Financial Management
Develop, track, and manage study budgets, including federal, industry, and pre-award budgets.
Maintain strong working relationships with sponsors, CROs, compliance offices, device manufacturers, the CNC and CTFS accounting teams, and University administrative units.
Oversee study startup, feasibility assessments, site logistics, staff training, and maintenance ofessential documents.
Coordinate mission-critical study activities, including:
Investigational product/device accountability
DSMB interactions
Scheduling of surgical procedures, admissions, monitoring stays, and device- related
visits.
Harmonization of research procedures across inpatient and outpatient environments
Represent the Epilepsy Institute on internal committees, cross-departmental teams, and external sponsor or collaborative meetings.
Lead and implement program/project-management systems ensuring milestones, enrollment targets, regulatory deliverables, and timelines are met.
Report directly to the Director of Research as the operational lead for implementing departmental research standards and strategic priorities within the Epilepsy Institute.
Provide regular updates, performance metrics, and risk assessments to the Director of Research and collaborate to align Institute processes with department-wide expectations and compliance frameworks.
Clinical/Scientific Operations & Strategic Execution
Collaborate with investigators and study teams to ensure high-quality data collection and adherence to protocol requirements.
Monitor study progress, enrollment trends, and outcomes data; recommend protocol or workflow modifications to maintain scientific integrity and operational feasibility.
Draft or contribute to progress reports, presentations, publications, and regulatory summaries.
Stay current with scientific and clinical developments in epilepsy, neuromodulation, and clinical trial methodology to enhance study design and operational excellence.
Partner with clinic nurses, technologists, and providers to ensure seamless integration of research workflows into clinical operations.

Benefits

Competitive wages, paid holidays, and generous time off
Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
Low-cost medical, dental, and pharmacy plans
Healthcare and dependent care flexible spending accounts
University HSA contributions
Disability and employer-paid life insurance
Employee wellbeing program
Excellent retirement plans with employer contribution
Public Service Loan Forgiveness (PSLF) opportunity
Financial counseling services
Employee Assistance Program with eight sessions of counseling at no cost
Employee Transit Pass with free or reduced rates in the Twin Cities metro area