Research Pro 1/2 - Regulatory Specialist

Apply for Job Job ID 365506
Location Twin Cities
Job Family Research
Full/Part Time Full-Time
Regular/Temporary Regular
Job Code 8351RF
Employee Class Civil Service
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About the Job

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

Qualifications

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, p.