Position Summary
The Assistant Director of Research - Clinical Manager provides clinical and operational leadership for the Department of Obstetrics and Gynecology's clinical research program. This position oversees the day-to-day clinical operations and implementation of clinical research studies, ensuring protocols are conducted in accordance with Good Clinical Practice (GCP), applicable regulatory standards, institutional requirements, and departmental goals and priorities.
Working closely with the Director of Research Operations, Vice Chair(s) of Research, departmental leadership, investigators, research staff, sponsors, monitors, and clinical partners, the Assistant Director of Research - Clinical Manager provides clinical expertise and operational oversight across the department's clinical trial portfolio. The position is responsible for effective management of clinical trials, department-wide study start-up and activation, and supervision and development of clinical research staff.
The Assistant Director of Research - Clinical Manager serves as a key departmental resource for clinical research operations, supporting investigators in the development and implementation of research studies, monitoring portfolio performance, identifying resource and staffing needs, and developing processes to improve research quality, efficiency, compliance, and participant experience.

Duties/Responsibilities:
Clinical Trial Management - 40%
Provides clinical and nursing expertise to interpret and operationalize research protocols.

Oversees the day-to-day clinical operations and implementation of assigned clinical trials.

Collaborates with Principal Investigators (PIs) and study teams to recruit, screen, and enroll study participants.

Ensures study-required clinical procedures are appropriately executed in collaboration with clinical staff.

Provides or oversees participant education throughout the duration of the study regarding treatment plans, anticipated side effects, monitoring guidelines, and follow-up.

Ensures accurate source documentation, including documentation of research visits in the EMR.

Oversees identification and reporting of serious adverse events, stopping rules, dose-limiting toxicities, and protocol deviations according to institutional and sponsor-required timelines.

Oversees tracking systems for patient visits, protocol-required data collection, and other study procedures.

Troubleshoots operational and clinical challenges in the development and implementation of protocol procedures.

Participates in sponsor, monitor, site initiation, interim monitoring, and closeout visits.

Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, laboratories, and other departments across campus to execute study activities according to protocol.

Monitors enrollment, study milestones, visit completion, data collection, and overall trial performance.

Ensures research documentation and protocol compliance are maintained at high standards consistent with monitoring, auditing, and regulatory requirements.

Supports study closeout activities and ensures appropriate reconciliation of study documentation, data, supplies, and other study materials.

Serves as a clinical research resource and subject matter expert for investigators and research staff.

Develops and implements strategies to improve recruitment, retention, study workflows, and overall trial efficiency.

Provides regular updates to departmental leadership regarding clinical trial performance, enrollment, staffing, barriers, and resource needs.

Study Start-Up and Activation - 30%
Provides leadership and oversight for study start-up and activation activities across the Department of Obstetrics and Gynecology.

Reviews protocols and study materials to determine clinical, operational, staffing, and resource requirements.

Provides clinical research expertise during feasibility assessments and study planning.

Coordinates study start-up activities with investigators, sponsors, monitors, research teams, and institutional departments.

Oversees preparation and submission of required regulatory and institutional documents in collaboration with research staff and appropriate institutional offices.

Assists with IRB submissions, amendments, continuing reviews, and other regulatory requirements.

Ensures collection and maintenance of required investigator and study staff documentation, including licenses, CVs, training records, financial disclosures, and delegation documentation.

Coordinates study-specific training, site initiation visits, and other requirements necessary for study activation.

Develops and maintains study start-up tracking systems to monitor outstanding requirements, timelines, and activation milestones.

Collaborates with investigators and research staff to develop study-specific workflows, recruitment strategies, visit schedules, and operational plans.

Identifies barriers to study activation and leads efforts to resolve clinical, operational, regulatory, and resource-related issues.

Ensures clinical and operational readiness prior to study activation and participant enrollment.

Serves as a departmental resource for consistent and efficient study start-up practices.

Develops and standardizes study start-up processes, tools, and workflows across the OBGYN research portfolio.

Works collaboratively with departmental and institutional research leadership to improve study activation timelines and operational readiness.

Assists investigators in assessing the feasibility and operational requirements of new clinical research opportunities.

Staff Supervision, Leadership, and Study Lead - 30%
Fosters an environment of excellence for clinical research staff that supports the mission, vision, goals, and objectives of the Department of Obstetrics and Gynecology.

Provides day-to-day leadership, supervision, mentorship, and guidance to assigned research staff.

Manages, mentors, and evaluates assigned staff in collaboration with departmental leadership.

Oversees research staff workload and study assignments to ensure balanced and appropriate support across the clinical research portfolio.

Identifies staffing deficiencies, workload concerns, and resource needs and works with departmental leadership to address them.

Supports recruitment, onboarding, professional development, and retention of highly engaged and competent research staff.

Ensures new hires are appropriately trained on departmental research operational standards and study-specific requirements.

Develops and maintains orientation materials, training resources, and competency assessments.

Provides task-level guidance and mentorship to research coordinators and clinical research staff.

Serves as study lead for designated clinical trials, providing operational and clinical oversight of assigned studies.

Establishes and maintains staff proficiency with applicable guidelines and requirements governing clinical research conduct, performance, monitoring, auditing, and reporting.

Engages staff in cross-functional process improvement initiatives and serves as a liaison to other areas of the organization.

Qualifications

Required Qualifications
Bachelor's degree in Nursing, or equivalent combination of education and experience to equal 6 years. OR advanced degree plus at least 4 years of relevant experience
Current license to practice as a Registered Nurse in the State of Minnesota.
Demonstrated experience in clinical research coordination and clinical trial management.
Demonstrated leadership or supervisory experience in a clinical or research environment.
Demonstrated ability to lead, problem solve, prioritize, and make decisions in an environment of rapid change.
Demonstrated ability to manage multiple studies, priorities, and competing deadlines.
Excellent verbal and written communication skills.

Preferred Qualifications
Experience managing clinical trials within Obstetrics and Gynecology, Women's Health, or a related specialty.
Experience managing a clinical research team or research program.
Experience with study start-up, feasibility assessment, and site activation.
Clinical research certification such as CCRC, CCRP, or equivalent.
Experience with sponsor-initiated, federally funded, and investigator-initiated clinical research.
Experience developing departmental research processes, SOPs, and quality improvement initiatives.

Pay and Benefits

Pay Range: $120,000 - $130,000; 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

While our salary ranges provide a framework, it is important to note that most of the
time, the initial pay may not reach the maximum of the range. This approach ensures
that compensation reflects the value and unique contributions of each candidate while
maintaining equity within our organization. As part of our commitment to fair and
equitable compensation, please be aware that the salary offered to incoming candidates
will be based on their individual credentials and experience.

How To Apply

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

This position will remain open until filled.

To request an accommodation during the application process, please e-mail [email protected].