Posted in Other about 3 hours ago.
Location: Coral Gables, Florida
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Manager, Research Support
The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Manager, Research Support to work at the UHealth Medical Campus.
Core Summary
The Manager, Research Support provides grant application and management support to facilitate research. Further the Manager, Research Support oversees research operations to ensure efficiency and compliance with applicable regulations.
Core Responsibilities
Contributes to basic and applied research activities by collecting and analyzing data and maintaining databases.
Understands and interprets research protocols and procedures and ensures all research is undertaken according to best practices.
Provides guidance, mentorship, and oversight to junior research staff and students.
Conducts meetings with research and other staff, outside agencies, and other applicable organizations and ensures functions are coordinated in a timely and accurate manner.
Provides technical and program support and resolves operational problems.
Assists in the preparation and publication of manuscripts and other program-related documents and reports.
Stays abreast of developments in the field which may impact department functions.
Advances expertise through continued education, training, and research.
Adheres to University and unit-level policies and procedures and safeguards University and unit-level policies and procedures and safeguards University assets.
Department Specific Functions
The Multiple Sclerosis Division has an exciting opportunity for Manager, Research Administration /Regulatory Specialist to serve as the lead to a busy research team in the MS Division, Department of Neurology. This position will be also responsible for the regulatory work of the active clinical trials in the program. The selected candidate will supervise a team of 5 clinical research coordinators and/or research assistants, oversee workload, and ensure the program compliance with all policies and regulations of the University. It will support principal Investigators and Clinical Research Coordinator (CRC) with aspects of regulatory submissions, maintaining the regulatory files and binders. It will coordinate monitors' visits from sponsors and assist Division Administrator with creating clinical trials feasibility forms.
Supervise staff of 5 in the MS Research Division Team.
Oversee CRC's workload and compliance with University Research Policies.
Work with Sr. Division Administrator to maintain the adequate infrastructure to facilitate research processes.
Prepare financial feasibility analysis for each study.
Act as a liaison with sponsors, grant managers, Office of Research Administration, IRB among others.
Assist or supervise the CRCs with process of regulatory document submission to the Institutional Review Boards (IRB) including communicating with ancillary committees and industry sponsors.
Assist the CRCs with the process of regulatory document submission to the FDA for investigator held IND studies.
Maintain all the studies (approx. 20) regulatory binders.
Supervise the collection and maintenance of credentialing information including Principal Investigators and study team training records, curriculum vitae, and research education records.
Assist the CRCs during audits and site visits with monitors concerning regulatory documents.
Update principal investigators with regards to institutional requirements for protocol development and conduct of research trials.
Assist CRC in filing of IND safety reports.
Work with Divisional Administrator to set up new studies and to create clinical trials feasibility forms.
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 required
Minimum 3 years of relevant experience
Knowledge, Skills and Attitudes:
Working knowledge of clinical trials, Federal, State and Local Regulations, ICH-GCP and FDA Guidances, IRB requirements and submissions, consent form writing, and protocol development.
Computer skills including MS Office products, Internet, and general computer proficiency required.
Excellent skills in time management, priorization, and multi-tasking required.
Excellent communication skills both written and oral.
Bilingual preferred.
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 for additional information.
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