Regulatory Analyst - Remote

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 - Remote to work at the UHealth campus in Miami, Fl.

The Regulatory Analyst 1 - Remote UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment matrix to identify possible cancers from claims data.

Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. Oversees accurate and timely processing, tracking, and filing of federally mandated submissions. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. Provides support to investigators by reviewing submissions for content. Sends decision correspondence to appropriate parties, requesting information.

Maintains accurate databases and generates letters. Develops and maintains templates, creates files, and mails notices. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Education: Bachelor's degree in relevant field

Experience: Minimum 1 Year Of Relevant Experience

• Skill in completing assignments accurately and with attention to detail.
• Ability to communicate effectively in both oral and written form.
• Ability to handle difficult and stressful situations with professional composure.
• Ability to maintain effective interpersonal relationships.
• Ability to understand and follow instructions.

• Attend SDG Meetings to provide regulatory updates and guidance.
• Build and maintain a working relationship with regulatory staff and provide guidance to Regulatory Specialist (RS).
• Review protocol package for completion after PRC approval has been granted to guarantee the following documents are included:
  • Protocol Document
  • Consent Form(s)
  • IND Approval or Exemption Letter
  • Investigator’s Brochure
  • Draft Budget
  • CTA
  • Patient documents (if applicable)
  • Recruitment materials (if applicable)
  • External DSMB charter (if applicable)
• Assist the Sr. Regulatory Analyst (RA) in the aspects of regulatory related issues.
• Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
• Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance.
• Completion of the new protocol submission packet with the information provided by PRC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. In addition, must follow the entire initial submission process until the new study is approved.
• Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL). Ensure in conjunction with the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• Attend required regulatory meetings.
• Update Trial Master File (TMF) for multi-center research trials.
• Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email. This responsibility is sponsor-dependent. The following documents may be included:
  • Financial Disclosure Forms
  • FDA 1572
  • Initial Protocol Signature…