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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Sr. Regulatory Analyst to work at the UHealth Medical Campus in Miami, FL.

The Sr. Regulatory Analyst will be responsible for assisting the Population Sciences Research Operations Office of Regulatory Services/Behavioral and Community-Based Shared Research of the Sylvester Comprehensive Cancer Center with submissions to the Protocol Review and Monitoring Committee (PRMC), IRB and other ancillary committees for all cancer related studies submitted for review. This individual will provide support for the on-going research studies and activities, and will work closely with the PRMC staff, investigators and research staff to ensure adherence to institutional standards.

PRIMARY DUTIES & RESPONSIBILITIES:

Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance.Request and obtain the initial regulatory packet from the protocol investigator/sponsor or designated Clinical Research Organization (CRO), if applicable. Design, conduct, and coordinate the delivery of education and training programs for investigators, study coordinators, and staff performing any related research activities.Assist with development of new processes and standard operating procedures (SOPs). Develop small group training sessions to address areas of frequent research non-compliance as indicated by audit findings.Verify the following credentials for investigator(s) and study team member(s) listed on the PRMC Submission Form are current: Curriculum Vitae (CV), Medical License (as applicable), University of Miami Conflict of Interest (COI), Collaborative Institutional Training Initiative (CITI), and  Good Clinical Practice (GCP)Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). In addition, must follow the entire initial submission process until the new study is approved.Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL). Ensure in conjunction with the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder. Attend required regulatory meetings for all study protocols.Organize and store protocol files including but are not limited to all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions.Communication with PI, study team and/or sponsor in order to organize and prepare the Protocol Response Letter for the Protocol Review and Monitoring Committee (PRMC) when required until final approval is granted.Assist managers with verifying adherence to audit response commitments and work with the CAPA lead coordinator.Attend PSG meetings to provide regulatory updates and guidance.Perform other duties as assigned.

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.

REQUIRED QUALIFICATIONS:

Bachelor’s Degree required.Three years Regulatory Affairs experience in the research setting or equivalent combination of studies and relevant work experience inclusive of substantial experience in regulatory affairs.CRP certified preferred. Strong organizational, analytic and communication skills.Any relevant education, certifications and/or work experience may be considered.

KSA:

Knowledge of National Cancer Institute (NCI) guidelines in regard to PRMS and IRB policies and procedures, as well as industry regulations for clinical trials preferred. Ability to work well in a fast paced environment and manage multiple tasks simultaneously and independently.Familiarity with medical terminology and clinical research protocols including human subjects research applications.Proficiency with Microsoft Office products.

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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.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

H9