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 Department of Medicine, Division of Infectious Diseases, has an exciting opportunity for a Full Time Manager, Clinical Research to work in the UHealth campus. The Manager, Clinical Research oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies; and coordinates work with Study Managers and other relevantteam members to assure the fidelity of study protocols and data collection.Core Responsibilities
Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation.
Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.
Assembles project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
Manages investigator relationships.
Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA.
Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.
Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.
Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.
Interacts with project team members to define submission logistics and workflow scheduling.
Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system.
Prepares and presents the annual summary report for clinical trial and research areas.
Provides consultation and guidance for UM held INDs and IDEs.
Develops, implements, maintains and oversees internal policies and SOPs as well as University‐wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices.
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.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.
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 QUALIFICATIONSMaster’s degree in relevant fieldMinimum 5 years of relevant experience Knowledge of business and management principles. Ability to direct, manage, implement, and evaluate department operations. Ability to establish department goals, and objectives that support the strategic plan. Ability to effectively plan, delegate and/or supervise the work of others. Ability to lead, motivate, develop, and train others.#LI-EL1 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 timeEmployee Type:StaffPay Grade:A13
