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) . Manager, Clinical Research The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Manager, Clinical Research to work at the UHealth Medical Campus.Core Summary The Manager, Clinical Research (A) 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 relevant team 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.
Department Specific Functions Research Management RCMAR/T32/MBI
Work with principal investigators and study team on research reports
Update DOH with quarterly grant deliverable reports
Manage Internal Review Board (IRB) study proposals, submissions, continuing reviews, amendments, for local and central IRBs
Manage research databases including, reports, team access, permissions
Maintain awareness of research project goals, timelines, deadlines, oversee implementation and quality control
Assist Program Directors with coordinating training program, coordinating didactic programs (virtual & live)
Plan, implement, evaluate and monitor multiple programs per the RCMAR grant
Implement project plans related to the delivery of new and on-going programs
Work with internal team members to ensure the program operates efficiently/effectively
Evaluate and measure effectiveness of assigned programs
Coordinate pilot award training program for NIH Center Grant for 4 Scholars per 18-month award cycle
Assist Center Director with soliciting applications, organizing peer reviews, selecting awardees, coordinating training program, coordinating didactic programs (virtual & live), arranging travel, preparing progress reports for NIH, and adhering to protocols and training timelines
in development of newsletters and website content
Serve as research liaison with faculty, collaborators, trainees, departments, disciplines and institutes
Implement research strategic plan goals/objectives, track progress
Coordinate and write annual MBI progress report
Coordinate scientific research meetings and journal clubs
Core Qualifications
Bachelor's degree in relevant field
Minimum 5 years of relevant experience
Knowledge, Skills and Attitudes:
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.
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 timeEmployee Type:StaffPay Grade:A13
