Regulatory Analyst 2

University of Miami; Miami (FL); Hybrid; USD 70,000 - 95,000; Full time

Job summary

The University of Miami invites applicants for a Regulatory Analyst 2 at the UHealth campus in Miami, FL. This full-time hybrid role focuses on regulatory submissions from study start-up through closure, and maintenance of regulatory documents to ensure compliance with FDA, NIH, and university SOPs.

Key duties include coordinating IRB submissions, drafting protocol materials and consent forms, maintaining regulatory binders, and communicating with study teams, sponsors, and committees to ensure

Qualifications

• Bachelor's degree in a relevant field.
• CCRP certification, if applicable.
• Minimum 2 years of relevant regulatory experience.
• Knowledge of federal, state, and local regulations.
• Experience with clinical trial procedures.
• Strong written and oral communication skills.

Responsibilities

• Oversee regulatory submissions and maintain regulatory documents.
• Coordinate IRB submissions from activation to closure.
• Prepare protocol and consent form documentation.
• Maintain regulatory binders and DOAL logs.
• Communicate submission status in team meetings.

Skills

Regulatory knowledge

Clinical trial knowledge

Attention to detail

Effective communication

Interpersonal skills

Education

Bachelor's degree

CCRP certification

Job description

## Regulatory Analyst 2Applyremote type: Hybridlocations: Miami, FLtime type: Full timeposted on: Posted Todayjob requisition id: R100097663**Current Employees:**If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.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 Responsibilities: * 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.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***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.*****MINIMUM QUALIFICATIONS:*** Bachelor's degree in relevant field* CCRP if applicable* Minimum 2 year of relevant experience* Knowledge of relevant federal, state, and local regulations* Knowledge of procedures associated with clinical trials* 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.***Any appropriate combination of relevant education, experience and/or certifications may be considered.***#LI-YC1