Clinical Research Regulatory & Quality Specialist

The primary purpose of this position is to independently manage pediatric clinical studies according to regulatory requirements, institutional guidelines, and sponsor expectations. The Regulatory Specialist facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory standards within the group. Duties include comprehensive regulatory management of active and new clinical studies, facilitating study start-up, ensuring compliance with University reporting requirements, and maintaining records of investigator and staff qualifications. Clinical studies may be inclusive of Sponsored or Sponsor-Investigator studies, both single and multi-site. This position will have a strong focus in study start-up submission, along with leading the education of study staff on regulatory-related study management. This position reports to the Senior Regulatory Manager but is accountable to the program leaders, project managers, the physician-investigators, and members of the clinical research team.

Regulatory Processes for Opening New Clinical Studies (60%)

• Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management and eBinders systems.
• In collaboration with the PI and Primary Research Coordinator, interpret study protocols and develop consent form documents, prepare IRB submissions, and respond to requests for modifications.
• Provides PI consultation and guidance in regulatory requirements for the development of Investigator-Initiated protocol; develop consent forms, prepare IRB submissions, respond to requests for modifications.
• Facilitate accurate and timely completion of additional regulatory documents.
• Shepherd submissions and correspondence through the processes until approvals are obtained.
• Create regulatory files and binders for new studies.
• Support the development of electronic consent forms in REDcap.
• Prepare for and participate in site selection and site initiation visits. Lead project managers in identifying regulatory needs during these processes and intake.

Regulatory Management of Ongoing Clinical Studies (20%)

• Ongoing regulatory management including preparation and submission of protocol amendments and other changes, and ensuring timely annual reviews.
• Maintaining protocol information and documents in the Clinical Trials Management and eBinder systems.
• Facilitate completion of additional regulatory documents.
• Independently tracks IRB submissions, approvals, and pending expirations; ensuring deadlines are met to avoid a lapse in approval.
• Maintain version control of all IRB-approved study documents.
• Maintain regulatory binders and required documentation to ensure compliance with regulations, University policies, and Sponsor expectations.
• Prepare for and participate in monitoring visits, program audits, etc.
• Coordinate processing of outside safety reports and local serious adverse events; ensure PI assessment per IRB and sponsor requirements.
• Report Unanticipated Problems Involving Risk to Subject and Others (UPIRTSO) per IRB requirements.
• Independently provides the investigators and team guidance for ensuring all regulatory reporting requirements are met.

Research Education (10%)

• Attend professional development and training sessions to ensure compliance with newest policies and procedures.
• Serve as a lead regulatory resource for the research teams, research sponsors, and University review committees.
• Mentor and be a lead resources to Clinical Research Coordinators in Regulatory Management of human subject's research.
• Identify, develop and lead professional development, education and training sessions with program staff.

Quality & Process Improvement (10%)

• Assist in identifying, developing, discussing, and implementing new procedures.
• Support other special projects and program initiatives as directed; may complete independently, or lead initiatives and projects with other program staff (e.g. project managers, coordinators).
• Support quality assurance and monitoring on studies as assigned by Senior Regulatory Manager.
• Assist with quality monitoring according to departmental procedures

All required qualifications must be documented on application materials

Required Qualifications:

• Bachelor's degree in health, public health, biomedical disciplines plus at least 4 years of relevant experience in clinical research; or advanced degree plus at least two years of relevant experience, or a combination of related education and work experience in research totaling eight years.
• Experience with regulations governing research activity (such as but not limited to GCPs, FDA regulations and ICH guidelines).
• Experience interpreting clinical research protocols.
• Computer proficiency, and ability to navigate multiple software applications with electronic document management experience, especially Adobe and Microsoft.
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as a part of a team and with changing priorities
• Excellent written, verbal and interpersonal skills

Preferred Qualifications:

• Previous professional experience on a clinical research project team or similar environment , such as clinical research coordinator or research assistant or regulatory specialist
• Experience in a Pediatric clinical research setting
• Experience in an academic medicine setting
• Experience writing and adapting patient consent forms for research studies
• Experience preparing and managing IRB and other regulatory review submissions
• Clinical Research certification, or willing to sit for exam within 12 months of hire
• Familiarity with Clinical Trial Management Systems including OnCore and electronic regulatory systems including Florence

At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standards of care for children across the country and around the world.

The Pediatric Clinical Research Services program supports a variety of research projects and portfolios in the Department of Pediatrics. We serve the University's research mission by providing comprehensive research support to faculty investigators conducting medical research in neonates, infants, children, adolescents, and young adults. We accomplish our mission by 1) developing competent professionals specialized in pediatric clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.

We especially strive to have our community better reflect the broad range of identities in our state, including race, ethnicity, gender identity, gender expression, sexual orientation, language, disability, age, national origin, religious practice, access to health services, and socioeconomic status. Our program seeks to foster an inclusive environment in which members from diverse backgrounds are encouraged to develop their skills of scientific inquiry.

Pay Range: $70,000/year - $80,000/year; depending on education/qualifications/experience

Time Appointment: 50%-74% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented 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
• 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

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).

The University of Minnesota Medical School

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.