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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 FileDevelop and create in-service program on IRB submission and study start up for junior faculty at Miller School of MedicineDirect hands-on addition of appropriate administrative text and required language to study protocolsDevelop Corrective and Preventive Action (CAPA)Review adverse events, serious adverse events for regulatory requirements and IRB submissionOversee 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 trainingCommunicate 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 protocolsProtocol amendments, administrative and clarification lettersInformed Consent forms (IC), such as the Main Consent, Pregnancy Follow-Up Consent, Genetic Consent, HIV Consent and AddendumsContractsAudit findingsHIPAA formsTranslated documentsInvestigator's brochures or package insertsAdverse eventsIND safety reportsData safety/monitoring reports or other sponsor reportsContinuing/final reportsRecruitment materialsQuestionnairesProtocol deviationsStudy specific menusSubject general guidelinesSubject payment formsIRB 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 MeetingsMaintain 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