Assistant Director of Epilepsy Research Operations

Position Summary:

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.

Duties/Responsibilities:

1. Staff Leadership, Oversight, & Team Development (34%) - Primary Focus
* 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.

2. Administrative, Operational, & Financial Management (33%)
*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:
o Investigational product/device accountability
o DSMB interactions
o Scheduling of surgical procedures, admissions, monitoring stays, and device- related
visits.
o 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.

3. Clinical/Scientific Operations & Strategic Execution (33%)
*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.

Required Qualifications
*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.

Preferred Qualifications:
*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.

The Comprehensive Epilepsy Institute at the University of Minnesota is the first epilepsy institute built toward developing therapies to cure epilepsy. The Comprehensive Epilepsy Institute brings together leading clinicians, scientists, and industry partners to accelerate the discovery, testing, and delivery of transformative treatments. The Institute integrates cutting-edge clinical trials, device-based neuromodulation research, biomarker discovery, surgical innovation, and world class imaging into a unified research and patient care ecosystem. By bridging laboratory breakthroughs with real-world clinical expertise, the Institute is designed to advance therapies beyond seizure control, toward prevention, restoration, and ultimately a cure for epilepsy. The Comprehensive Epilepsy Institute supports clinical trials, device-based neuromodulation studies, biomarker discovery, surgical and non-surgical epilepsy interventions, and observational research.

To learn more about the Department of Neurology, please visit https://med.umn.edu/neurology.

Pay Range: $96,000 - $120,000 annually; depending on education/qualifications/experience.

Time Appointment: 100% Appointment

Position Type: Faculty and P&A Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• 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

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).