Regulatory Analyst 1 - Remote

University of Miami•Miami, FL

3d•Remote

About The Position

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.

Requirements

Bachelor's degree in relevant field
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.

Responsibilities

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 Page Amendments signature page Investigators CV and Medical Licenses Laboratories normal ranges and certifications IRB approvals Approved consents Other documents as required by the sponsor
Communicate to the Regulatory Manager relevant aspects of the regulatory process that need improvement.
Assist with the submission of an Investigational New Drug (FDA Form 1572) application to the FDA for institutional clinical trials.
Assist in preparing regulatory documentation packets and create FDA 1572 Forms for IND filings.
Assist PI with writing audit responses and follow-up on observation close-outs.
Assist in maintenance of regulatory-related internal tracking databases and filing systems.
Assist in compilation of regulatory-related metrics for use by senior management.
Assist in the creation and maintenance of policies and procedures for the Regulatory Department (e.g. SOPs) as well as preparing PowerPoint presentations for SOP implementation and/or training.
Ensure all necessary forms are submitted to the trial sponsor.
Post regulatory documents including protocols, amendments, consent forms and safety reports to the CTMS system.
Other duties as assigned.