Regulatory Specialist

Are you ready to embark on a transformative journey in clinical and translational research? As part of the University of Minnesota's Clinical and Translational Research Services, we are passionate about research; transforming possibilities and driving innovation. We're on a mission to elevate the game of clinical and translational research, and we're looking for passionate individuals to join us on this exhilarating adventure!

Clinical and Translational Research Services (CTRS) is not your typical support unit - we're a powerhouse of dynamic individuals dedicated to revolutionizing the landscape of research at the University of Minnesota. We thrive on collaboration, find inspiration in creative solutions and always aim for excellence.

About the Role

The Regulatory Specialist is an important role in the Clinical Research Support Center at the University of Minnesota, facilitating the compliant execution of clinical trials, and assisting in the development and maintenance of regulatory standards within the group. You'll be responsible for the regulatory processes necessary to make clinical trials available to patients following federal regulations, as well as the sponsor and University policies. This includes creating and maintaining regulatory documents, as well as adapting participant consent forms in compliance with sponsor and local standards. You'll act as a liaison for the sponsor, principal investigator, research study teams, review committees and monitors (internal & external) to the IRB; addressing issues of study rationale, implementation, and safety monitoring. Additionally, this position will monitor trends in regulatory/protocol processes and make recommendations for improvement. And play a key role in providing guidance to ensure regulatory documents are filed and archived, providing education, training and serving as a resource to improve research compliance.

Work location: Hybrid; occasional on-site presence required

Salary Range: $68,000-$78,000

DUTIES/RESPONSIBILITIES

40% Regulatory Processes for Opening New Trials

• Creating regulatory files for new studies.
• Completing IRB and other required review committee applications on assigned protocols.
• Drafting study-specific participant consent form documents according to sponsor and University requirements.
• Drafting study-related correspondence for study PI.
• Creating all required documents for assigned regulatory files.
• Assisting PI and research manager with coordination of regulatory activities relative to initiation of assigned clinical trials.
• Communicating with other University and hospital departments to collect needed information for initiating new trials and opening study research accounts.
• Assisting research team in preparation for audits/monitoring visits.

35% Regulatory Processes for Continued Management of Active Trials

• Facilitating continuing review compliance for IRB annual reviews.
• Processing study amendments and revising consent forms as needed.
• Communicating with department faculty and staff regarding pertinent changes to protocol-specific requirements.
• Communicating with other University and hospital departments regarding pertinent changes to protocol requirements.
• Preparing regulatory approval applications, responding to stipulations, and shepherding applications and correspondence through the processes until approvals are obtained.
• Tracking all regulatory review submissions and approvals to ensure deadlines are met.
• Providing guidance on the maintenance of regulatory documentation to ensure compliance and audit-readiness at any given time.

10% Risk Management

• Triaging and documenting outside safety reports and local serious adverse events.
• Reporting unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline.
• Submitting Reportable New Information to the IRB within the required timeline.

10% Process Improvement

• Assisting in the development of standard operating procedures for regulatory processes.
• Entering information into study management database and creating accurate reports for the research team.
• Monitoring trends in regulatory/protocol processes and making recommendations for improvement.
• Assisting with implementing changes in regulatory processes as needed.

5% Group Leadership, New Procedures, and Training of New Staff

• Assisting in identifying, developing, discussing, and implementing new procedures.
• Assisting with monitoring according to departmental procedures.
• Participating in the training of new staff as requested.
• Fulfilling special requests for data management and other duties as assigned.

Qualifications

All required qualifications must be documented on application materials.

Required Qualifications

• BS/BA and 4 years' experience in clinical research setting or an advanced degree and 2 years' experience or an equivalent combination of education and experience to total eight years.

Relevant experience includes:

• Working in a clinical research setting.
• Submitting to an Institutional Review Board.
• Maintaining clinical research documentation.

Preferred Qualifications

• BS/BA or Masters degree in a health related field.
• Additional professional experience on a clinical research project team or similar environment.
• Experience in an academic medicine setting.
• Work experience demonstrating ability to multitask and prioritize.
• Experience independently maintaining deadlines and prioritizing assignments.
• Work experience initiating and processing multiple projects simultaneously.
• Work experience providing customer service to internal and external clients.

About the Department

The University of Minnesota Clinical and Translational Science Institute (CTSI) mission is to accelerate and improve clinical and translational science research, education and improve health. CTSI provides consultation, training, support, and services to researchers and research teams across the translational continuum. CTSI is part of the national, NIH-funded Clinical Translational Science Award (CTSA) program/consortium that works together to improve the efficiency, quality, and impact of clinical and translational research and science.

Benefits

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 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

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

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 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.

Diversity

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

Employment Requirements

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.

Employment Requirements

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.

About the U of M

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).