Job Description: Job Title: Sr. Regulatory Analyst Pay Grade: C105 Pay Band Min / Max: $46,900.00 - $75,000.00 Position Number: P100017396 Department / Hospital: SCCC 18 - STA
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 Regulatory Manager 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 Sr. 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.
DUTIES & RESPONSIBILITIES:
Job duties will include, but not be limited to:
1. Attend SDG Meetings to provide regulatory updates and guidance.
2. Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
3. Participate in the audit response and CAPA processes to identify, recommend, and implement corrective and preventive actions for regulatory and other related processes with the guidance of senior leadership.
4. Verify that implemented corrective and preventive actions are suitable and effective by conducting quality assurance (QA) & quality control (QC) checks on active clinical trials.
5. Assist with training of all regulatory affairs personnel with regards to regulatory compliance.
6. Act as a mentor for new employees and find ways to improve the department's mentorship program.
7. Work directly with senior management to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems.
8. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses.
9. 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)
10. 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.
11. 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 initial approval throughout the completion of the study. • Amendments/modifications • Reportable new information • Protocol Deviations /violations, • Protocol exceptions, • IND safety letters, • Continuing/final reports, and • Other communications from the sponsor requiring IRB submission.
12. Communication with PI and study team in order to organize and prepare Investigator Initiated protocol amendments to the scientific committee (PRC) for approval prior to IRB submission. Assist PI in addressing communications from PRC requiring protocol amendments or other changes in the study.
13. Preparation and maintenance of regulatory binder and H: drive with all necessary study documentation.
14. 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.
15. Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Communicate with Clinical 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.
16. Conduct regular internal QC of open and enrolling protocols and/or protocols determined to be of high risk to human subjects.
17. Assist PI with writing audit responses and follow-up on observation close-outs.
18. Maintain of regulatory-related internal tracking databases and filing systems.
19. Compile regulatory-related metrics for use by senior management.
20. Assist in the creation and maintenance of policies and procedures for the Regulatory Department (e.g. SOPs) as well as in the preparation of PowerPoint presentations for SOP implementation and/or training.
21. Assist in the collection and maintenance of credentialing information for study personnel. Such include protocol specific training records, conflict of interest forms (COI), and CITI training.
22. Assist in the preparation of annual reports to the FDA.
23. Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications.
24. 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
25. Other duties as assigned by senior management.
Requirements include Bachelor's degree and 5+ 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.
• Computer skills and Microsoft Office skills (Outlook email, Word, Excel, PowerPoint) required. • Excellent English skills (both oral and written) required. • Excellent skills in time management, prioritization, and multi-tasking required. • Exceptional organizational skills. • Ability to utilize sound judgment, analyze problems, provides solutions and makes decisions. • Ability to communicate effectively both in writing and verbally. • Accountable for their own productivity and for the quality and consistency of their completed work. • Demonstrates a high respect for confidentiality.
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 Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information- https://www.hr.miami.edu/careers/employment-laws-eo/index.html
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.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.