Manager, Regulatory Support

Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/EReRecruitingApplyforaJob.pdf) . The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Manager, Regulatory Support to work at the UHealth Medical Campus in Miami, FL 33146.CORE JOB SUMMARYThe Manager, Regulatory Support establishes, manages, and meets the milestones of clinical studies in compliance with applicable clinical and regulatory standards related to human subject protocols. This role ensures training and mentoring of all RSQA clinical research monitors. Additionally, the incumbent provides clinical monitoring oversight for CRO vendors.CORE JOB FUNCTIONS1. Oversees a team of RSQA clinical research monitors for investigational site monitoring and studyactivities.2. Identifies study issues and implements solutions, including identifying and involving the appropriatedecision-makers.3. Anticipates data needs and implements tools for effective study management. Assists in database designand data reports.4. Facilitates the development of site training documentation and materials. Assists in the creation andmaintenance of print and web-based policy and procedure manuals.5. Contributes to the development and writing of clinical protocols, case report forms, and other studydocuments for investigational studies. Conducts co-monitoring visits with RSQA clinical researchmonitors.6. Evaluates quality and completeness of data, and participant safety documentation, and ensurescompliance with research regulations and protocols. Monitors new legislation or changes in regulationsthat might affect the University's compliance in conducting research, and recommends changes toadministrative policies and procedures.7. Generates monitoring reports and follow up letters of findings, and tracks corrections to resolution.Maintains records of monitoring activities, and prepares reports, responses, and follow-up activities.8. Provides expert consultation on quality control and regulatory issues to research sites and investigatorsvia on-site visits. Advises appropriate institutional officials of deficiencies and recommends necessarycorrective actions, with follow up to ensure that needed actions have been implemented.9. Conducts internal and external audit preparations. Remains in compliance with federal, state, and localregulations, and extramural agencies' requirements.10. Assists with the preparation and presentation of educational programs to groups and individuals in theUniversity research community. Provides regulatory support to principal investigators and researchteams.11. Assists in the creation and maintenance of a CAPA (corrective action preventive action) system.12. Maintains RSQA related databases, and electronic and paper audit files. Assists with the preparation ofannual reports of RSQA, summarizing efforts taken and changes to be implemented at both Universityand department levels.13. Establishes and continuously assesses the effectiveness of the internal controls within the unit andcompliance with university policies and procedures.

Ensures employees are trained on controls within the function and on university policy and procedures.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include otherduties or responsibilities as necessary.

CORE QUALIFICATIONSEducation: Bachelor’s degree in relevant fieldExperience: Minimum 5 years of relevant experienceKnowledge, 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 Ability to recognize, analyze, and solve a variety of problems Ability to exercise sound judgment in making critical decisions DUTIES & RESPONSIBILITIES:Provide quality assurance/ 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. Request and obtain the initial regulatory packet from the protocol investigator/sponsor or designated Clinical Research Organization (CRO), if applicable. Design, conduct, and coordinate the delivery of education and training programs for investigators, study coordinators, and staff performing any related research activities. Assist with development and quality control (QC) of new processes and standard operating procedures (SOPs). Develop small group training sessions to address areas of frequent research non-compliance as indicated by audit findings. Create, develop, and maintain a library of handouts, training materials, slide presentations, and manuals. Provide continuing quality control of research activities by reviewing research subject folders. Coordinate the entire process of pre-submission to the Protocol Review and Monitoring Committee (PRMC) including communicating with ancillary committees, study team, business office, and sponsors for document support but not limited to: Consent Form (s) Protocol Budget Contract IND Approval or Exemption Letter (if applicable) Investigator’s Brochure (if applicable) Patient documents (if applicable) Recruitment materials (if applicable) External DSMB charter (if applicable) Verify the following credentials for investigator(s) and study team member(s) listed on the PRMC Submission Form are current: Curriculum Vitae (CV) Medical License (as applicable) University of Miami Conflict of Interest (COI) Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) Development and submission of IRB initial protocol. 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.). 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 for all BCSR study protocols. Organize and store protocol files including but are not limited to all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions. Communication with PI, study team and/or sponsor in order to organize and prepare the Protocol Response Letter for the Protocol Review and Monitoring Committee (PRMC) when required until final approval is granted. Assist investigators with the interpretation of regulations and UM Sponsored programs requirements for each study submissions. Assist managers with verifying adherence to audit response commitments and serve as the CAPA lead coordinator. Attend PSG meetings to provide regulatory updates and guidance. Perform other duties as assigned.#LI-YC1The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.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 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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:H13