Clinical Research Program Manager

Working Title: Clinical Research Program Manager

Job Code Title: Research Manager 1 - Clinical Research Project Management

Job Code: 9391CP

Position Summary:

The Clinical Research Program Manager provides clinical research management expertise across a diverse portfolio, including investigator-initiated, federally funded (e.g., NIH), and industry-sponsored Phase I-IV trials within the Dermatology Research Division.

Collaborating closely with the Division Director, the Program Manager leads the clinical research program, manages complex studies, and drives institutional process improvement initiatives. This role requires strong analytical and technical skills, comprehensive project management expertise, and a deep understanding of clinical and laboratory processes. Additionally, the Program Manager is responsible for mentoring and guiding research staff and trainees.

Job Responsibilities:

Program Management and Strategic Leadership (30%)

• Lead the Dermatology clinical research program services, working closely with the director of the Research Division on strategic planning.
• Work collaboratively; with department administrative leadership to insure division success.
• Serve as an expert consultant on clinical research across multiple departments, disciplines, and/or diseases/conditions, driving institutional process improvement efforts.
• Provide professional clinical research expertise and guidance to Dermatology faculty and investigators regarding protocol feasibility, conflicts of interest, regulatory compliance, resource options, subject population, timelines, and budget.
• Oversee quality control and internal monitoring activities within the research program.
• Manage the successful research operations of the program, including leading cross-functional teams, managing timelines, budgets, and requirements using project management methodologies.
• Work collaboratively with Department research staff to facilitate weekly clinical research meetings and track action items.
• Work collaboratively with the Dermatology Finance to oversee the research portfolio budget and financial reporting.
• Compiles reports/presentations on program activity; analyzes historical data and trends; determines impact on existing and future operations.
• Represent the department in medical school, CTSI, IRB, and SPA meetings and initiatives.
• Provide staff with training of systems and processes.

Project Management (30%)

• Responsible for managing and supporting of all aspects of clinical research projects, ensuring timely delivery of results and high-quality outcomes.
• Oversees the planning, project management of clinical studies for the life-cycle of the study from site selection through study close out to include:
  • Site feasibility
  • Stie selection
  • Site start up process (contract, budget, and regulatory processes)
  • Monitoring the status of enrollment
  • Assuring clinical trials are audit ready
  • Close out and storage of studies
  • Investigator Initiated Trials study execution and resources
  • NIH /Federal and internal /eternal grants support for study initiation
• Working with the Medical School pre-award staff, provide clinical research expertise to assist with preparation of grant documents in accordance with funding requests.
• System Integration: Navigate and master University systems (ETHOS, OnCore, REDCap, MNGEMS, eFlorence) to create a streamlined workflow.

Study Coordination (20%)

• Serve as the back-up and/or primary Clinical Research Coordinator for the conduct and oversight of multiple research studies. Must be proficient in screening, consenting, and enrolling subjects to ensure study continuity.
• Independently facilitate the successful implementation of protocols in multiple research settings, including participant recruitment, enrollment, study visits, and data collection according to protocol, sponsor requirements, and Good Clinical Practice guidelines.
• Oversee or track subject visits, ensuring protocol timelines are met.
• Ensure source documents and laboratory processes are in place for study visits.
• Oversee or enter all study and subject data into the OnCore clinical trials management system and required sponsor platforms.
• Prepare for and respond to study monitor reports according to sponsor, CTSI, and IRB procedures.

Regulatory Compliance and Oversight (10%)

• Ensure compliance with protocol regulatory regulations and overall clinical objectives; assure that all IRB, FDA, and other regulations are followed.
• Oversee or participate in the preparation of study-related documents such as protocol worksheets, procedural manuals, and adverse event reports.
• Records adverse events and side effect data and confers with investigators regarding reporting of events to oversight agencies.
• Keep Investigators and staff up to date on training requirements, new guidelines, and regulations.
• Provide training, review, and assistance to staff and faculty with IRB applications and associated forms (e.g., continuing review, change in protocol, reporting of events).
• Lead and guide faculty and staff with Institutional Review Board (IRB) materials and regulatory submissions, ensuring the department is "audit-ready" at all times.

Supervision, and Mentorship (10%)

• Provides clinical research mentorship, education and training for Department research staff, fellows, medical, and graduate students involved in research projects.
• Interviews applicants, assigns schedules, directs work, and evaluates the work of colleagues and/or coworkers.
• Supervision: Manage the hiring, training, and performance evaluation of the clinical research coordinators.
• May include supervised of student employees.
• Conflict Resolution: Partner with the Department Leadership and Human Resources to resolve complex employee relations and performance issues.
• Provide training and direction to staff for new systems and processes.

All required qualifications must be documented on application materials.

Required Qualifications:

• BA/BS in a health-related field with at least six (6) years of clinical or research experience, OR an advanced degree with at least four (4) years of clinical or research experience.
• Relevant and direct experience in clinical research to include working with the IRB, data management, and following clinical research Standard Operating Procedures (SOPs), the Code of Federal Regulations for clinical trials, and Good Clinical Practice (GCP) guidelines.
• Experience with laboratory guidelines and handling clinical research samples.
• Relevant and direct experience with regulatory requirements including study monitoring, IRB, and IND/IDE submissions.
• Proven ability to communicate effectively and clearly in both verbal and written formats.

Preferred Qualifications:

• Clinical Research Coordinator certification (e.g. CCRC).
• Experience with research databases, including RedCAP and OnCore.
• Experience reading and interpreting the scientific literature.
• Previous experience with Dermatology.
• Experience in both adult and pediatric studies.

The Department of Dermatology is committed to providing excellent patient care, conducting investigational research, and training the next generation of dermatologists. We have world-renowned clinical programs, nationally recognized educational program, and pioneering clinical trials. We are dedicated to improving dermatological care, not only for today, but also for the future.

For more information, please visit our website at https://med.umn.edu/dermatology.

Pay Range: $98,092.80 - $110,000 annually and we anticipate most offers will be around the midpoint of this range, depending on education and experience.

Time Appointment: 100% Appointment

Position Type: 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).