Regulatory Specialist 1 or 2 (Research Professional 1 or 2)

Job Class: 8351RF or 8352RF - Research Professional 1 or 2 - Regulatory Affairs Specialist
Working Title: Regulatory Specialist 1 or 2
Supervisor: Deb Mailand

About the Job:
In close partnership with the Program Manager(s) (PM), the Regulatory Specialist (RS) facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory documents and standards within the group.

Responsibilities include: Perform regulatory processes necessary to make clinical trials available to patients following federal regulations, good clinical practice as well as sponsor and University policies. This includes: creating and maintaining regulatory documents, ensuring all are filed and archived properly; creating and adapting subject consent forms in compliance with sponsor and local standards; acting as a liaison with sponsor, principal investigator, research coordinators, review committees and monitors (internal & external); addressing regulatory issues of study rationale, implementation, and safety monitoring; monitoring trends in regulatory/protocol processes and making recommendations for improvement; and providing education, training and serving as a resource to improve research compliance.

This hybrid position will primarily work independently with day-to-day activities; and report to a Program Manager within the team. The successful candidate should expect to be in the office routinely, 3+ days per week. The ability to work remotely exists and is dependent on work duties (i.e. data only days can be remote).

This position is not eligible for visa sponsorship.

Specific duties include:

1. Regulatory Processes for Opening New Studies (35%)

• Serves as primary contact for purposes of collection and completion of required regulatory documentation.
• Completes IRB and other required review committee applications on assigned protocols
• In partnership with the Project Manager, prepares regulatory approval applications, responds to stipulations, and shepherds applications and correspondence through the processes until approvals are obtained.
• Drafts study-specific subject consent form documents and recruitment materials according to sponsor and University requirements.
• Under direction of Project Manager, completes and maintains all required documents for assigned regulatory files.
• Assists PI, Program Manager and Research team with all activities relative to initiation of assigned clinical trials.
• Communicates with other University departments and clinical partners to collect needed information for initiating new trials and opening study research accounts.
• Uploads regulatory documents in OnCore and completes associated fields.
• RP2 coordinates and facilitates the submission of Investigational New Drug (IND) and/or
  Investigational Device Exemption (IDE) applications.

2. Regulatory Processes for Continued Management of Studies (45%)

• Utilizes knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules to oversee project specific regulatory activities. Applies knowledge to the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials while protecting the safety and health of human subjects and meeting regulatory compliance requirements.
• Facilitates the submission of amendments, annual reviews, reportable new information, and other regulatory submissions. Tracks all regulatory review submissions and approvals to ensure deadlines are met.
• Communicates with PI and Research team regarding pertinent changes to protocol-specific requirements.
• Communicates with other University departments and clinical partners pertinent changes to protocol requirements.
• Under the direction of the Project Manager, maintains regulatory documentation to ensure compliance and audit-readiness at any given time
• Ensures UMN required systems are complete and accurate (OnCore, CTSI portal, ETHOS, MN-GEMS).
• Assists with compliance and entry within clintrials.gov, ETHOS and other regulatory portals.
• Participates in study close-out actions as needed, including archival storage.
• Coordinates the processing of outside safety reports and local serious adverse events.
• Reports unanticipated problems involving risk to subjects and others (UPIRTSO) within the required timeline.
• Under the direction of the Project Manager, reviews monitoring reports, data quality responsiveness, identifies and resolves problems with determined action plans with SurgCTO processes and resourcing.
• Under the direction of the Project Manager, assists with the development and implementation of Corrective and Preventative Action (CAPA) plans.
• In collaboration with research team, provides support and oversees visits with outside sponsors, which may include prequalification, site initiation, interim visits and closeout visits.
• Contributes as a regulatory subject matter expert through all phases of a clinical study, in partnership with Senior Regulatory Specialists or Project Managers
• RP2 serves as the regulatory subject matter expert through all phases of a clinical study.

3. Process Improvement & Quality Assurance (15%)

• Assists in providing education, training, and serves as a resource to improve research compliance.
• Assists in the development of standard operating procedures for regulatory processes.
• Monitors trends in regulatory/protocol processes and makes recommendations for improvement.
• Assists with implementing changes in regulatory processes as needed.
• Assists with internal audits and QC projects.
• RP2 assists with internal audits and QC projects and may lead components of internal regulatory
  quality improvement initiatives or prepare teams for external audits.

4. Other Duties as Assigned (5%)

• Supports other special projects and program initiatives as directed.
• Attends professional development and training sessions to ensure compliance with newest policies and procedures.
• RP2 will serve as subject matter expert resource for others on the team with regard to regulatory
  expertise
  

The employer reserves the right to change or assign other duties to this position.

Required Qualifications for RP1RF:

• BA/BS degree, or a combination of education and relevant work experience to equal at least four years.
• Computer proficiency, and ability to navigate multiple software applications
• Electronic document management experience and strong skills with, Adobe and Microsoft Word
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as part of a team, with changing priorities
• Demonstrated ability to independently meet deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills

Required Qualifications for RP2RF:

• BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years.
• Deep knowledge of the federal regulations governing human subject research, including protections for vulnerable populations
• Experience preparing and managing IRB and other regulatory review submissions, including securing initial IRB approvals and required University of Minnesota & Fairview pre-review
  approvals.
• Computer proficiency, and ability to navigate multiple software applications
• Electronic document management experience and strong skills with Florence eBinders, OnCore, REDCap, Adobe, and Microsoft Word
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as part of a team, with changing priorities
• Demonstrated ability to independently meet deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
  

Preferred Qualifications:

• Previous experience in an academic medical setting
• Experience with human subjects research
• Working knowledge of the federal regulations governing human subject research, including protections for vulnerable populations
• Experience with setting up OnCore clinical management system, utilizing Florence and REDCap
• Experience preparing and managing IRB and other regulatory review submissions, including securing initial IRB approvals and required pre-review approvals.
• Experience maintaining regulatory binders
• Previous professional experience on a clinical research project team or similar environment
• Certification: National certification in area of specialty or related area preferred. Clinical Research Certification (CCRC or CCRP)
• Research or clinical experience in an interventional specialty

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.

To learn more about the Department of Surgery, please visit https://med.umn.edu/surgery

Pay Range: Regulatory Specialist 1: $57,000 - $61,000 OR Regulatory Specialist 2: $66,000 - $72,000; depending on education/qualifications/experience

Time Appointment: 100% 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 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).