About the Job
The purpose of this role is to manage, coordinate, and facilitate the conduct of research studies, including UMN-led multi-site projects in the Department of Medicine. This includes working closely with faculty PI's in the development of research projects and the implementation of study protocols as well as overseeing and ensuring IRB approval and compliance, and monitoring the project progress (enrollment, data, financial) throughout the life of the project. The successful candidate will be a self-starter with excellent people skills and the ability to manage multiple and changing priorities and deadlines. In-depth research-specific knowledge is imperative to success in this role.
Research Study Operations & Regulatory Management (90%):
* Provide study and regulatory oversight of sites participating in multi-site investigator initiated studies or UMN-led multi-site projects.
* Prepare and obtain regulatory (IRB and ancillary review) approval, respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained.
* Maintain regulatory documentation and TMF to ensure compliance and audit-ready at any given time.
* Conduct routine internal QA monitoring to ensure compliance with regulatory requirements & promote the maintenance of organized, accurate, and complete participant and study records.
* Ensure that all study start-up requirements have been met at all sites, including the collection and completion of all essential regulatory documents and regulatory committee approvals.
* In collaboration with the Principal Investigator, assist with the development and creation of multi-site protocols, consent documents, study manuals, study-specific questionnaires/handouts, case report forms, recruitment materials, etc.
* Ensure required UMN systems are complete and accurate (OnCore, CTSI portal)
* Provide guidance on study setup, and identification of and collaboration with clinical partners, including with IDS, biostats, CRU, CSC, UMMC, etc. and on visit schedules, activity logs, source documents.
* Assess study needs, evaluate feasibility and provide input to facilitate study implementation
* Create and modify operating procedures, study overviews, work instructions, and other training documents. Coordinator and lead Site Initiation Visits.
* Serve as primary contact for all site staff and coordinate the dissemination of study information, including protocol amendments and other updates to sites in a timely manner.
* Provide oversight of ongoing study activities by leading site meetings, communicating regularly with sites, UMN PI, and other internal and external stakeholders on start-up activities and study progress.
* Provide regulatory guidance and direction to all members of the research team and sites in order to ensure compliance with all applicable policies, procedures and regulations.
* Assist with the review of site safety events and protocol deviations, including drafting CAPAs and implementing protocol/workflow changes, quality control reviews, evaluation reports, and retraining plans as applicable
* Coordinate the processing of outside safety reports and serious adverse events and dissemination to and acknowledgement from sites.
* Report unanticipated problems involving risk to subjects or others (UPIRTSO), SAE, and other RNIs within the required timelines
* Develop study implementation plans relating to patient recruitment, enrollment, study protocol procedures, participant retention, and other processes as needed
* Track study progress and ensure target milestones are met as applicable throughout the life cycle of the study.
* Guide the conduct of studies in a manner that ensures the integrity of data and safety of participants at all sites.
* Complete continuing reviews for active studies; assist sites with completion of regulatory approvals
* Verify that regulatory documents, quality data, monitoring activities and other contracted requirements have been completed at each site at the time of study completion.
* Assist in the creation and maintenance of detailed clinical trial budgets/contracts
* Monitor study budgets, resolve budget deficits or financial queries to ensure fiscal responsibility.
* Evaluate any issues with study-specific billing, taking necessary steps to resolve & prevent future occurrences if applicable.
* Investigate non-compliance issues that arise and assist with revision of the protocol, re-education of the study team or modification of the team approach to the project as needed, including meeting directly with principal investigators to do study problem solving and redesign when necessary
Process Improvement and Monitoring (10%):
* Contribute in identifying, developing, discussing, and implementing new procedures
* Fulfill special requests for data management and other duties as assigned
* Utilize institutional research and regulatory knowledge to advise investigators on required university policies and/or federal regulations related to clinical research processes.
* Aid in the development of standard operating procedures for research and regulatory processes
* Monitor trends in regulatory/protocol processes and make recommendations for improvement
* Assist with implementing changes in research and regulatory processes as needed
* Serve as a liaison internally and externally to share expertise, information, and assistance regarding protocols and clinical research to advance research aims
* Delegate research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome.
* Other duties as assigned

All required qualifications must be included in the application materials

Required Qualifications:
* BA/BS and at least 5 years of experience or advanced degree and 3 years of experience or a combination of related education and work experience to equal nine years
* Demonstrated experience initiating and managing research projects, including expertise with regulatory or site management
* Computer proficiency and ability to navigate multiple software applications; experience with computerized data management
* Proven detail-oriented with exceptional organizational, planning and problem-solving skills
* Demonstrated ability to maintain deadlines and prioritize assignments
* Excellent written, verbal and interpersonal skills; demonstrated writing skills in a technical or medical setting
* Knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research

Preferred Qualifications:
* Previous experience in an academic setting
* Experience with OnCore clinical trial management system
* Experience with regulations governing research activity (GCP, FDA, ICH, etc.)
* Working knowledge of UMN research policies, procedures, resources, and systems

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also 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
• 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)
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

Please visit the for more information regarding benefits.

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:

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).