Regulatory Analyst - Remote

Regulatory Analyst 1 - UHealth

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

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

• 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.

CORE QUALIFICATIONS

• Education: Bachelor's degree in relevant field required
• Experience: Minimum 1 year of relevant experience required
• Knowledge, Skills and Abilities:
• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

Department Specific Functions

Job duties will include, but not be limited to:

Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.

Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e., local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required.

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 study start-up throughout the completion of the study.

• Initial IRB application
• Amendments / modifications
• Reportable new information
• Protocol deviations / violations
• Protocol exceptions
• IND safety letters
• Continuing and final reports
• Other communications from the sponsor requiring IRB submission.

Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.

Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.

Maintains department credentialing information and research records for clinical trials within institution's electronic systems (e.g., Velos, Complion) and appropriate drives, as applicable.

Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.

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.

Assist in the collection and maintenance of credentialing information for study personnel (e.g., study-specific training, IBC, EHS requirements, etc.).

Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.

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.

Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.

Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. 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

Provide feedback to Regulatory Management on opportunities for regulatory process improvement.

Identifies and escalates issues before they become critical.

Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.

Other duties as assigned by senior management.

Education:

• Bachelor's degree required
• Any relevant education, certifications and/or work experience may be considered.

Experience:

• Minimum one (1) year of relevant experience in compliance, research, or a medical setting.
• Experience in clinical trials is preferred.