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/ER\_eRecruiting\_ApplyforaJob.pdf) . The University of Miami/UHealth Department of Clinical Pharmacology has an exciting opportunity for a Full Time Manager, Compliance to work in the UHealth Campus. 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. CORE JOB FUNCTIONS + Develops, implements, and oversees regulatory compliance strategies for the department. + Initiates development of standard operating procedures for monitoring and auditing of clinical trials. + Ensures trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes, and regulations. + Generates, submits, and follows-up on Investigational New Drugs (IND) submissions and Series Adverse Effects (SAE). + Interfaces with and serves as liaison to regulatory agencies. Also serves as liaison to other institutional monitoring and audit groups. + Reviews proposed changes to submissions and advises whether the changes require regulatory approval. Responds to regulatory agencies to address questions or deficiencies in submissions. + Maintains regulatory agency correspondence files. + Leads the design of monitoring programs to ensure human and animal safety. + Identifies training and educational needs regarding clinical and manufacturing practices. + Identifies and ranks areas at risk of exposure and recommends strategies to address issues. + Develops systems and relationships to support auditing activity, and organizes panels of experts to assist in reviews and analyses. + Identifies and reports general compliance issues that may arise through the work process, and writes and revises standard operating procedures. + Reviews technical publications, articles, and abstracts to stay abreast of current regulations and trends, and ensures appropriate actions are taken to incorporate necessary revisions into the workplace environment. + Collaborates with and advises the Institutional Conflicts of Interest Committee on management plans. + Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures. Department Specific Functions + Advises the study PI on protocol adherence, requirements for protocol amendments, FDA Code of Federal Regulations and ICH-Good Clinical Practice compliance. + Supervises Research Personnel in aspects of human subject protection to ensure that performance of study protocols adheres to ICH-GCP and FDA guidelines. + Initiates via email 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: + 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 + 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 correspondence + Regulatory and IRB affairs. Submit research protocols, amendments, corresponding IC and other documents as listed above to the IRB. + Handle all IRB and regulatory correspondence. + Communicate with Sponsors, and Contract Research Organizations (CROs) + Maintain records in regulatory binders per study up to date. + Prepare for Sponsor Site Initiation Meetings + Assist with FDA, Sponsor, and UM quality assurance audits + Keep and maintain ongoing and future study protocols and informed consents up to date. + Maintain all study staff training records 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. 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. CORE QUALIFICATIONS Bachelor’s degree 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 Any relevant education, certifications and/or work experience may be considered. 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. 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 time Employee Type: Staff Pay Grade: H10