University of Rochester Health Project Coord in Rochester, New York

Opening

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

Schedule

8 AM-4:30 PM

Responsibilities

General Purpose:

Coordinates and oversees regulatory activities for the Clinical Trials Office in the James P. Wilmot Cancer Center.

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.

Typical Duties:

Serves as regulatory research development coordinator for investigators in Hematology/Oncology. Works with the principal investigator (PI) and the Clinical Trials Office (CTO) Administrative Director in all phases of planning and conduct of research projects, which may include but are not limited to:

Protocol preparation and activation

  • Prepare protocols and write consent forms for submission to the University of Rochester regulatory committees:Disease-Oriented-Groups (D.O.G.), Cancer Center Protocol Review Committee (PRC), and Institutional Review Boards (IRBs).
  • Prepare, submit, track and respond to IND requirements, where applicable, including annual and ongoing safety reporting.
  • Plan and coordinate trial activities for multi-center studies, when applicable.
  • Serve as primary point of contact with investigators within the Cancer Center.This includes contacting the study sponsors, chairpersons or statisticians for clarifications required for IRB submission.
  • Collaborate with finance coordinator to determine any non-standard-of-care tests and procedures that may need pricing and special requisitions.
  • Prepare DOG/PRC packet for distribution.
  • Prior to activation of protocols, ensure budget contact has provided any special requisitions and/or reimbursement forms to study coordinator.
  • Arrange site activation meetings for clinical research protocols

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

  • 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. Other duties as required.

Qualifications:

Bachelor’s degree in nursing, allied health, social or technical field and at least 2-3 years of clinical trials related experience (3-5 years’ experience preferred), or an appropriate combination of education and experience. Certification as a CRA, CRC or clinical research professional preferred. Experience with computer databases, forms development, word processing, and document tracking required. Excellent communication and organization skills are important.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Health Project Coord

Location: School of Medicine & Dentistry

Job ID: 204432

Regular/Temporary: Regular

Full/Part Time: Full-Time