Regulatory Analyst

Position: Regulatory Analyst 2

Full Time Regulatory Analyst 2

The University of Miami/UHealth Department of SCCC invites applications for a full‑time Regulatory Analyst 2 to work at the UHealth medical campus in Miami, FL.

CORE JOB SUMMARY

The Regulatory Analyst 2 reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start‑up through study closure, and maintains regulatory documents to ensure compliance with applicable requirements and regulations.

CORE JOB FUNCTIONS

Oversee and provide support for the process of study submissions (initial and amendment) and regulatory document maintenance; serve as point of contact for various boards, committees, industry, academic, and cooperative sponsors. Submit or assist in the submission of applications for institutional clinical trials. Send decision correspondence to appropriate parties, requesting information. Assist with drafting, preparation, and presentation of programs to investigators and research staff to raise awareness of research compliance.

Maintain current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations). Ensure compliance of general and study‑specific regulatory processes with institutional SOPs, FDA, NIH, and other applicable regulations. Adhere to University and unit‑level policies and procedures and safeguard 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 a relevant field.

Experience

Minimum 2 years 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 ADDENDUM

This individual will assist the senior staff of the Office of Regulatory Services (ORS) for Population Sciences and Cancer Disparity Behavioral and Community‑Based Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center in the day‑to‑day operations of the office. The position requires knowledge of IRB policies and procedures, and federal regulations for clinical trials.

Responsibilities include preparing and coordinating the regulatory document submission process to the Institutional Review Board (IRB) from study activation to study closure, communicating with ancillary committees, study team, business office, and sponsors. Completing new protocol submission packets with information from PRMC and any required documentation (e.g., local protocol, HIPAA forms). Modifying and standardizing consent forms for IRB submission. Compiling documents to prepare IRB submission forms to ensure protocol compliance with federal regulations.

Maintaining regulatory binders (paper or electronic) with all necessary study documentation in compliance with SOPs, sponsor requirements, and applicable regulations. Communicating with study staff to ensure maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensuring protocol‑related training is completed for all study personnel and documentation maintained. Reviewing and submitting protocol deviations and amendments with Research Coordinators and PIs.

Providing updates to the study team and/or management regarding submission statutes and approvals. Assisting with various regulatory related projects.

Department Specific Qualifications Education

Bachelor’s degree in any relevant field.

Certification and Licensing

CCRP if applicable.

Experience

Minimum 2 years of relevant experience.

Knowledge, Skills and Attitudes

• Knowledge of relevant federal, state, and local regulations.
• Knowledge of procedures associated with clinical trials.
• Any appropriate combination of relevant education, experience and/or certifications may be considered.

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

UHealth‑University…