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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work remotely.

CORE JOB SUMMARY
The Regulatory Analyst 1 – 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.

CORE JOB FUNCTIONS
1. Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough
knowledge of federal regulations and University policies.
2. Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
3. Assists with the drafting, preparation, and presentation of programs to investigators and their
research staff to raise awareness of research compliance.
4. Provides support to investigators by reviewing submissions for content.
5. Sends decision correspondence to appropriate parties, requesting information.
6. Maintains accurate databases and generates letters.
7. Develops and maintains templates, creates files, and mails notices.
8. 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.

CORE QUALIFICATIONS
Education: Bachelor's degree in relevant field

Experience: Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes:
• 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.
 

DEPARTMENT SPECIFICS:

1. Attend SDG Meetings to provide regulatory updates and guidance.

2. Coordinate the entire process of regulatory document submission to the Institutional Review Board

(IRB) including communicating with ancillary committees, study team, business office, contract

research organizations, and sponsors.

3. Participate in the audit response and CAPA processes to identify, recommend, and implement

corrective and preventive actions for regulatory and other related processes with the guidance of

senior leadership.

4. Verify that implemented corrective and preventive actions are suitable and effective by conducting

quality assurance (QA) & quality control (QC) checks on active clinical trials.

5. Assist with training of all regulatory affairs personnel with regards to regulatory compliance.

Act as a mentor for new employees and find ways to improve the department’s mentorship

program.

7. Work directly with senior management to examine opportunities for regulatory innovation and

promote the use of novel approaches within the project team to resolve issues and problems.

8. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting

of audit responses.

9. 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)

10. 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.

11. Compilation of documents in order to prepare the following forms for IRB submission to ensure

protocol compliance with federal regulations.

This process will take place from initial approval

throughout the completion of the study.

 Amendments/modifications

 Reportable new information

 Protocol Deviations /violations,

 Protocol exceptions,

 IND safety letters,

 Continuing/final reports, and

 Other communications from the sponsor requiring IRB submission.

12. Communication with PI and study team in order to organize and prepare Investigator Initiated

protocol amendments to the scientific committee (PRC) for approval prior to IRB submission.

Assist PI in addressing communications from PRC requiring protocol amendments or other

changes in the study.

13. Preparation and maintenance of regulatory binder and H: drive with all necessary study

documentation.

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.

15. Coordinate audits and site visits with monitors concerning compliance of regulatory documents.

Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and

amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring

visit.

16. Conduct regular internal QC of open and enrolling protocols and/or protocols determined to be of high risk to human subjects.

17. Assist PI with writing audit responses and follow-up on observation close-outs.

18. Maintain of regulatory-related internal tracking databases and filing systems.

19. Compile regulatory-related metrics for use by senior management.

20. Assist in the creation and maintenance of policies and procedures for the Regulatory Department

(e.g. SOPs) as well as in the preparation of PowerPoint presentations for SOP implementation

and/or training.

21. Assist in the collection and maintenance of credentialing information for study personnel. Such

include protocol specific training records, conflict of interest forms (COI), and CITI training.

22. Assist in the preparation of annual reports to the FDA.

23. Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications.

24. 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

25. Other duties as assigned by senior management.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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