Research Pro 1/2 - Regulatory Specialist

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.
  

A RP2RF will be expected to have more experience, require less training to get started, work more independently, and be able to manage a larger workload.

This hybrid position will primarily work independently with day-to-day activities; and report to a Program Manager within the team. The successful candidate will be expected to be in the office 2-3 days per week during the 6-month probationary period and a minimum of 1 day per week after passing probation.

Specific duties include:

• Regulatory Processes for Opening New Studies (35%)
  • Serves as primary contact for purposes of collection and completion of required regulatory
    documentations
  • Completes IRB and other required review committee applications on assigned protocols
  • 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.
  • Creates 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.
  • Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications.
• Regulatory Processes for Continued Management of Studies (45%)
  • Utilizes extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules
    to oversee SurgCTO 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.
  • 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,
    EGMS).
  • Oversees and ensures faculty are in compliance with clintrials.gov, ETHOS and other regulatory portals.
  • Facilitates 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.
  • Reviews monitoring reports, data quality responsiveness, identifies and resolves problems
    with determined action plans with SurgCTO processes and resourcing.
  • Implements Corrective and Preventative Action (CAPA) plans. Performs as liaison between
    the sponsor, investigator and governing body.In collaboration with research team, provides support and oversees visits with outside sponsors, which may include prequalification, site initiation, interim visits and closeout visits.
  • Serves as the regulatory subject matter expert through all phases of a clinical study.
• Process Improvement & Quality Assurance (15%)
  • Provides 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.
• 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.
    

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

Supervisor: TBD

All required qualifications must be documented on application materials

Required Qualifications for RP1RF:

• BA/BS degree, or a combination of education and relevant work experience to equal at least four years

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

Required Qualifications for RP1RF and RP2RF:

• Expert 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 pre-review approvals.
• 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

Preferred Qualifications:

• Previous experience in an academic medical setting
• Experience with setting up OnCore clinical management system, utilizing Florence and REDCap
• 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.

• 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).