Regulatory Analyst 1

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.
• Affords 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.

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

• The Clinical Research Services (CRS) Division of the Sylvester Comprehensive Cancer Center has an exciting opportunity for a Full-Time Regulatory Analyst to work on the UHealth Campus.
• The CRS is a centralized resource that enables cancer center clinical investigators easy access to support services to facilitate clinical trial management.
• The CRS Office is responsible for providing multiple levels of support for clinical research activities throughout the Cancer Center.
• Remote option is available for this position.
• The Regulatory Analyst will be responsible for assisting the senior leaders of the Regulatory Department of the Cancer Center Division of Clinical Research Services (CRS) with the day to day operations of the office.
• This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials.
• The Regulatory Analyst must be able to assist on the following studies: Investigator Initiated Trials (IITs), Industry Sponsored Trials, Cooperative Group Sponsored Trials and Compassionate (emergency/single patient) Trials.
• Prepare and Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation 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 activation throughout the completion of the study.
• 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.

Minimum Qualifications

• Bachelor’s Degree in relevant field
• Minimum 1 year of relevant experience
• Ability to maintain effective interpersonal relationships
• Ability to communicate effectively in both oral and written form
• Skill in collecting, organizing and analyzing data
• Proficiency in computer software (i.e. Microsoft Office)
• Knowledge of relevant federal, state, and local regulations
• Knowledge of procedures associated with clinical trials

Pay

Competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

Full time Employee Type: Staff