University of Rochester Sr Health Project Coord - 218188 in Rochester, New York
Sr Health Project Coord Job ID 218188Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 055 Peds M&D Hematology/OncologySchedule
8:30 AM-5 PMResponsibilities
Coordinates and oversees the Pediatric Clinical Research Program within the Division of Pediatric Hematology/Oncology including the cooperative group protocols through Children’s Oncology Group (COG) and Dana Farber Cancer Institute (DFCI), investigator-initiated, compassionate-use, and pharmaceutical research projects. The majority of the protocols that this division works with are through COG. There are about 70 open COG protocols.
Directs the planning, implementation, coordination, operation and evaluation of divisional procedures required to ensure quality clinical trial research within the Division of Pediatric Hematology/Oncology. Must possess expertise in the area of Research Subjects Review Board (RSRB), Office for Human Research Protections (OHRP) and or Federal Drug Administration clinical research regulations.
At a local level, this individual must have the ability to devise the necessary strategic methods required to assure the success of the research projects. This person must have the ability to carry out strategic planning which incorporates the needs of the disciplines, the institution, the cooperative group, and the patient while abiding by the federal regulations.
Coordinate and conduct the implementation of research studies to comply with cooperative group and national/local regulations. In this role, this person will serve as a liaison between the cooperative groups, departmental, and non-departmental personnel to assure that this institution is in compliance with study guidelines as detailed on the individual treatment protocols. Ensure timely completion of study documents. Phone communication and emails with cooperative groups, department and non-departmental personnel will be instrumental.
Maintain protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms, and case report forms.
Act as information resource to clinical staff for protocol specific queries. Over time, he or she will become familiar with the cooperative group protocols. At that time, he/she will be able to facilitate answering logistical questions pertaining to these studies such as eligibility questions, which protocols are open within this institution, knowing the status of the protocols, i.e. is the protocol temporarily closed to accrual.
Confirm study eligibility and enroll patients into cooperative group trials. Will review the treatment protocol specific eligibility requirements and enrollment procedures which are provided on the individual studies.
Review source documentation such as laboratory reports, operative notes, patient progress notes, and radiology scan result notes and record the results as per individual study guidelines. Ensure timely submission of this study data.
Ensures compliance with acceptable regulatory requirements and IRB standards. The regulatory agencies include the University IRB, clinical trials office, and the FDA. Ensure integrity of all study data collected. Ensures protocol activities are administered consistently across all studies. Will prepare and submit protocols, amendments, and annual progress reports to the IRB in compliance with the specified timelines from the cooperative groups. Keeps up-to-date with current federal regulations for conducting clinical studies according to Good Clinical Practice (GCP) Guidelines. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.
Develop University IRB approved informed consent documents for all protocols. These consents are generated by modifying an existing consent document from the individual cooperative group protocol.
Prepare for audits through the Institutional IRB which occur every 3 years. To prepare for an audit, he/she will collect all study documents for auditor review.
Bachelor's degree with major course work in an appropriate health, social or technical field, 3-5 years of related experience; or an equivalent combination of education and experience.
2 years prior experience as a Senior Health Project Coordinator
Certified Clinical Research Coordinator preferred
Bachelor’s degree in related field, or equivalent experience
Ongoing commitment to professional development
Knowledge of computer databases, word processing, spreadsheets, and graphics packages are important. No specific statistical program knowledge.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled