Regulatory Analyst 1

University of Miami•Miami, FL

3d•Remote

About The Position

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. 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. These centralized services include assistance with protocol development, regulatory affairs expertise, IND submission, study budgeting, contract negotiation, coordination of research nursing, data management, and safety reporting for all types of studies, including therapeutic, non-therapeutic, prevention and screening trials. 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. 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.
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
Any appropriate combination of relevant education, experience and/or certifications may be considered.

Responsibilities

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.
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.
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.