University of Rochester Health Project Coord in Rochester, New York
Full Time 40 hours Grade 053 Cancer Center/Clin Trials Ofc
8 AM-4:30 PM
Under general guidance and with latitude for exercise of independent judgement enter, analyze and ensure the accuracy and consistency of data for clinical research studies for the Clinical Trials Office of the James P. Wilmot Cancer Institute at the University of Rochester. Work collaboratively with study team on assigned oncology protocols. Maintain a working knowledge of the area(s) of expertise by reviewing research literature and abstracts, attending pertinent meetings and seminar, participate in the preparation of regulatory approvals and study documents. Assist with preparing analytical reports for publication.
Collaborates with study coordinators, sponsors, investigators, primary care physicians, and hospital staff in all phases of clinical research for the Cancer Center. Disseminates information to study investigator(s), team members, and sponsors. Develops, documents and implements data management processes and ensures compliance with all applicable regulatory and departmental SOPs, regulations and guidelines.
- Collects clinical data during all phases of care while patient is on-study, completes case report forms.
- Reviews and evaluates patient data for statistical analysis.
- Assists with study audits conducted by independent monitors and federal and governmental agencies.
- Assists with data analysis for long term projects.
Acts as liaison with sponsor’s monitor to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator and Sub Investigators, and to ensure case report forms are complete, accurate and available for review. Maintains accurate and up-to-date study subject binders. Communicates with sponsor to clarify data queries. Prepares for, participates in and serves as liaison for scheduled monitoring visits.
Assists with data analysis and preparation of materials for publication. Prepares and collates patient study information, status reports and updates as necessary for reporting on progress of patients enrolled in studies in order to accomplish a timely completion.
Performs ongoing quality assurance procedures, in order to ensure database integrity and that any data errors are identified quickly and corrected.
Maintains working knowledge of assigned diseases and research protocols. Maintains documentation of current training in required databases. Other duties as assigned.
Bachelor’s degree in a health related area or a current New York State Registered Professional Nurse license is preferred. Two to three years of direct patient care or clinical trials related experience. Excellent verbal and writing skills are required. Knowledge of computer databases, word processing, spreadsheets and graphics packages are important.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Health Project Coord
Location: School of Medicine & Dentistry
Job ID: 204431
Full/Part Time: Full-Time