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 using the Career worklet, please review this tip sheet. The Department of Medicine, Clinical Pharmacology Division has an exciting opportunity for a Temporary Manager, Compliance. The Manager, Compliance develops, implements, and oversees regulatory compliance strategies for the department. The incumbent on this position ensures that submitted research is reviewed efficiently and is consistent with regulations. The Manager, Compliance also documents communications with investigators, regulatory entities, and any other parties involved in the conduct of submitted research. Department Specific Functions The primary role of this position is Regulatory Administrator in the Division of Clinical Pharmacology. The Regulatory Administrator is responsible for the crucial processes of handling the regulatory (FDA), protocol adherence, human subject protection aspects of the research conducted in the Division of Clinical Pharmacology. At request of research administrators and coordinators, mentors regulatory specialists in creation and management of Investigator Site File Develop and create in-service program on IRB submission and study start up for junior faculty at Miller School of Medicine Direct hands-on addition of appropriate administrative text and required language to study protocols Develop Corrective and Preventive Action (CAPA) Review adverse events, serious adverse events for regulatory requirements and IRB submission Oversee NIH submissions and Pilot Study Projects for the duration of the studies. Train employees and colleagues on the UM and external IRB Electronic Protocol Submission and Tracking systems and processes. Manage training of employees on study protocols, amendments and other study modifications. Oversee and direct FDA, Sponsor, and UM quality assurance audits. Assist the PI in addressing audit findings, Corrective and Preventive Action (CAPA) and follow-up training Communicate with the IRB Chair, Associate Director, Administrators, and Reviewers to address and questions or concerns on the research projects. Provides advice to the study PI on protocol adherence, requirements for protocol amendments, FDA Code of Federal Regulations and ICH-Good Clinical Practice compliance. As such, this position oversees the entire research operation. Supervises Research Personnel in aspects of human subject protection to ensure that performance of study protocols adhere s to ICH-GCP and FDA guidelines. Initiating the process whereby all study subjects have a current signed and witnessed informed consent in their study record. Writes and formulates the Informed Consent and makes sure it contains standard required University of Miami language and format. Directly handles the preparation and submission to the IRB of the following documents in addition to addressing any questions or concerns from the IRB Chair, Administrators, and Reviewers on the research projects Oversees the following documents: Research protocols Protocol amendments, administrative and clarification letters Informed Consent forms (IC), such as the Main Consent, Pregnancy Follow-Up Consent, Genetic Consent, HIV Consent and Addendums Contracts Audit findings HIPAA forms Translated documents Investigator's brochures or package inserts Adverse events IND safety reports Data safety/monitoring reports or other sponsor reports Continuing/final reports Recruitment materials Questionnaires Protocol deviations Study specific menus Subject general guidelines Subject payment forms IRB and Jackson documents Studies are now also prepared and submitted for review by the Jackson Health System Committee (JHS) by completing specific forms, and all consent forms with the JHS footer. Primary Responsibilities Regulatory and IRB affairs. Submit research protocols, amendments, corresponding IC and other documents as listed above to the IRB. Interpret regulatory rules or changes and ensure that they are communicated to the PI and employees. Manage all IRB and regulatory documents. Coordinate efforts associated with the preparation of regulatory documents and submissions with Sponsors, and Contract Research Organizations (CROs) Oversee the maintenance of and update records in the regulatory binders per study. Prepare for Sponsor Site Initiation Meetings Maintain ongoing and future study protocols, informed consents, and other pertinent study documents up to date. Maintain all study staff training records and licenses up to date. Assist the director in maintaining and updating the standard operating procedures manual as required. Design and implement case report forms for investigator-initiated projects. Secondary responsibilities Arrange and supervise sponsor monitoring visits, site inspections and audits when requested by director. Assist the director as required. Other duties as assigned. 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 Requirements Bachelor’s degree or equivalent in relevant field Minimum 3 years of relevant experience Knowledge, Skills and Attitudes: Ability to maintain effective interpersonal relationships. Ability to communicate effectively in both oral and written form. Proficiency in computer software (i.e. Microsoft Office) Knowledge of business and management principles The 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. Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller 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. Job Status: Full time Employee Type: Temporary-Intermittent Pay Grade: H10 The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. Transforming lives With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe. The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.