The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common purpose of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making UM a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 13,400 faculty and staff from all over the world. The Clinical Research Services (CRS) division of the Sylvester Comprehensive Cancer Center 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. This individual 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 Compassionate (emergency/single patient) Trials. Job duties will include, but not be limited to: 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 the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder. Attend required regulatory meetings. Update Trial Master File (TMF) for multi-center research trials. Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email. This responsibility is sponsor-dependent. The following documents may be included: Financial Disclosure Forms FDA 1572 Initial Protocol Signature Page Amendments signature page Investigators CV and Medical Licenses Laboratories normal ranges and certifications IRB approvals Approved consents. Other documents as required by the sponsor Communicate to the Regulatory Manager relevant aspects of the regulatory process that need improvement. Assist with the submission of an Investigational New Drug (FDA Form 1572) application to the FDA for institutional clinical trials. Assist in preparing regulatory documentation packets and create FDA 1572 Forms for IND filings. Assist PI with writing audit responses and follow-up on observation close-outs.Assist in maintenance of regulatory-related internal tracking databases and filing systems. Assist in compilation of regulatory-related metrics for use by senior management. Assist in the creation and maintenance of policies and procedures for the Regulatory Department (e.g. SOPs) as well as preparing PowerPoint presentations for SOP implementation and/or training. Ensure all necessary forms are submitted to the trial sponsor. Post regulatory documents including protocols, amendments, consent forms and safety reports to the CTMS system. Other duties as assigned.
Requirements include Bachelor's degree and 2+ years Regulatory Affairs experience in the clinical research industry or equivalent combination of studies and relevant work experience inclusive of substantial experience in regulatory affairs. Skills: Good verbal and written communication and organizational skills. Ability to work well with a fast paced team of study personnel (PI, data and clinical). Ability to manage multiple tasks simultaneously and independently. Experience with computer systems and software, including databases, spreadsheets, and word processing. Experience with Microsoft Office software. Familiarity with clinical research protocols including human subjects’ applications and informed consent documents. Ability to maintain patient confidentiality. Familiarity with medical terminology. Any appropriate combination of relevant education, experience and/or certifications may be considered.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action-Veteran/Disability Employer. Come join us!
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University of Miami School of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.