Manager, Compliance

at  University of Miami

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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.

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.

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

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