University of Miami
Full Time Regulatory Analyst 2
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 2 to work at the UHealth medical campus in Miami, FL. The Regulatory Analyst 2 - UHealth reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations. Core Job Functions: Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations. Adheres to University and unit-level policies and procedures and safeguards University assets. Core Qualifications: Education: Bachelors degree in relevant field Experience: Minimum 2 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 Specific Functions: This individual will be responsible for assisting 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 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 2 must be able to assist with the following studies: 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, 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. Communicate with Research 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. Provides updates to the study team and/or management regarding submission statutes and approvals (e.g. initial and amendments) during internal team meetings and upon request. Assists with various regulatory related projects under the direction of the Manager of Regulatory. Department Specific Qualifications: Education: Bachelors 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/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 2 to work at the UHealth medical campus in Miami, FL. The Regulatory Analyst 2 - UHealth reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations. Core Job Functions: Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations. Adheres to University and unit-level policies and procedures and safeguards University assets. Core Qualifications: Education: Bachelors degree in relevant field Experience: Minimum 2 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 Specific Functions: This individual will be responsible for assisting 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 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 2 must be able to assist with the following studies: 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, 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. Communicate with Research 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. Provides updates to the study team and/or management regarding submission statutes and approvals (e.g. initial and amendments) during internal team meetings and upon request. Assists with various regulatory related projects under the direction of the Manager of Regulatory. Department Specific Qualifications: Education: Bachelors 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.