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University of Rochester Maintenance Regulatory Specialist - 228380 in Rochester, New York

Maintenance Regulatory Specialist Job ID 228380

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Cancer Center/Clin Trials Ofc

Responsibilities

General Purpose:

Coordinates and oversees regulatory activities for the Clinical Trials Office in the Wilmot Cancer Institute.

Specific Responsibilities:

Under general guidance and with latitude for exercise of independent judgment, coordinates specific aspects of protocol development and data management for investigator-initiated, cooperative group, and/or industry research for Hematology-Oncology division principal investigators including activation, maintenance, and closure.

General Description:

Works with the principal investigator to implement, operate, and maintain all regulatory oversight for clinical research activities. Provides professional direction within each research project. Manages protocol development, including meeting regulatory requirements with FDA, IRB, and funding agencies as needed. Works with Study Coordinator to ensure case report form and database development is in place prior to activation of assigned studies. Maintains a working knowledge of the area(s) of expertise by reviewing relevant literature and attending pertinent meetings and seminars. Assists the study team (PI and coordinators) with coordinating center activities, documentation, and databases. Assists Study Coordinators with study document management. Assists investigators with documentation required by granting authorities.

Supervision/Direction Received

Director – Finance and Regulatory Affairs

Typical Duties 80%

Protocol maintenance

  • Prepare all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees.

  • Submit IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active.

  • Supervise the distribution of protocols, addenda, memos to the Hematology/Oncology study coordinators, physicians, support staff, surgeons, pathology, radiation therapy, pharmacy, clinics, units, affiliates, and sponsor offices as needed.

  • Inform study coordinators and physicians when re-consents are required.

  • Assist with coordinating center functions as they relate to on-site and other site(s) participation in clinical trials and affiliate participation.

  • Prepare, submit, track, and respond to all regulatory (FDA and IRB) requirements, including safety and ongoing reporting for other site(s) participating.

  • Work with Sr. Study Coordinators to ensure clinical data from all sites (if applicable) is accurate and collected promptly by monitoring studies at each study site for conformity with study specific standard operating procedures and regulatory requirements, ensuring protocol compliance.

  • Maintain regulatory records and necessary correspondence records.

  • Prepare and submit progress reports and renewals to the IRB and sponsors.

Affiliates 15%

  • Acts as the primary liaison and resource for local on-site and affiliate members (physicians, nurses, coordinators) regarding protocol regulatory activities.

  • Train and serve as mentor/consultant for local and affiliate site study personnel regarding regulatory requirements & responsibilities.

  • Identify, provide, and maintain necessary regulatory documentation for all sites involved.

  • Maintain tracking files for SMH and its affiliates. These files contain information regarding which studies are planned, active, or closed for each site for which we have regulatory oversight.

  • Monitor requested regulatory submission requirements for all sites to ensure timeliness of submissions; alert coordinators in a timely fashion of needed information required for reports due.

Assist Study Coordinators and investigators with study document management and tracking. 5%

Other duties as required.

Machines/Equipment Used

Computer, Printer, Copier

Requirements

Bachelor's degree with major course work in an appropriate health, social or technical field and 2-3 years of related experience; or an equivalent combination of education and experience. Experience with data bases, forms development, word processing, and document tracking required. Excellent communication and organizational skills are essential.

Note: An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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