Regulatory Analyst - Remote

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Regulatory Analyst I to work at the UHealth campus in Miami, Fl.

The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure.

• Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors.
• Provides regulatory support for multiple clinical trials from study start-up through study closure.
• Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.
• Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents.
• Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets.
• Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

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.

• Education:
  
  Bachelor's Degree in relevant field.
• Experience:
  
  Minimum one (1) year of relevant experience in fields such as compliance, research, and/or medical/clinical.
• Knowledge, Skills, and Attitudes:
  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);
  Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers, and clients;
  Knowledge of processes associated with clinical trials;
  Knowledge of applicable federal, state, and local rules and regulations.

• Attend SDG Meetings to provide regulatory updates and guidance.
• Build and maintain a working relationship with regulatory staff and provide guidance to Regulatory Specialist (RS).
• Review protocol package for completion after PRC approval has been granted to guarantee the following documents are included:
  Protocol Document Consent Form(s) IND Approval or Exemption Letter Investigator’s Brochure Draft Budget CTA Patient documents (if applicable) Recruitment materials (if applicable) External DSMB charter (if applicable).
• Assist the Sr. Regulatory Analyst (RA) in the aspects of regulatory related issues.
• Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
• Provide regulatory support for new and ongoing research studies.
• Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance.
• Completion of the new protocol submission packet with the information provided by PRC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.).
• Modifying and standardizing consent forms for IRB submission is required.
• In addition, must follow the entire initial submission process until the new study is approved.
• Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL).
• Ensure in conjunction with…