University of Rochester Sr Health Project Coord - 231784 in Rochester, New York
Sr Health Project Coord Job ID 231784Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 055 Surgery- Cancer ControlSchedule
8 AM-4:30 PMResponsibilities
This position serves as the Clinical Trials Manager for the multi-site NCI Community Oncology Research Program (NCORP) Research Base. Under general guidance and with latitude to exercise independent judgment, coordinates research activities including study development, implementation, conduct, and data collection for the 20+ national affiliated sites in this clinical research program.
The Executive Director of Research for the NCORP Research Base.
Protocol Development (40%):Serves as the project manager to plan and execute required aspects of each research protocol, working with the PI, Study Chair and other health care professionals. Duties include, but are not limited to, the following • Organizes, arranges, and participates in protocol development meetings with Principal Investigators, research coordinators, programmers and data management staff. • Advises protocol study chair on study management procedures; • Develops and maintains a comprehensive workflow process for each protocol and timeline of all tasks to be completed for each study that includes all project phases, material procurement, start-up processes, training and implementing changes where needed.• Develops data collection tools, including case report forms, and performs pre-testing and pilot testing of all forms.• Ensures that all research team members understand the scope of each project as well as what they are individually responsible for; assesses team members’ abilities, allocates and assigns personnel and technical resources to meet specific protocol and general research needs. • Reviews and/or edits study documents.• Develops data tracking tools for each clinical trial to ensure appropriate monitoring of all data received.• Identifies required study supplies needed for each study, oversees ordering, preparation and maintenance of all supplies• Prepares detailed documentation of study procedures and data collection codes.• Analyzes and suggests improvements in flow of information, error detection/correction, etc; advises Principal Investigators in developing best practices and appropriate data handling procedures for each research project.• Supervises the Research Base team of protocol coordinators; performs annual reviews, absence & vacation approvals.• Leads weekly protocol management meetings focusing on specific protocol questions/issues and data management issues
Study Management/Liaison with Research Base Affiliates (40%):• Plans and executes required aspects of a national research program involving multiple research protocols working with on- and off-site investigators, clinical research coordinators, research nurses and other health care professionals. Duties include, but are not limited to, the following:• Responsible for directing research activities of off-site study coordinators and research nurses (250) at 20+ sites nationally in all aspects of study implementation, study conduct and data collection procedures; maintains active verbal and written correspondence with investigators and study coordinators nationally re: study conduct for each clinical research protocol. • Ensures the smooth implementation of multiple research projects into existing clinical settings.• Trains study coordinators in procedures specific to each project. • Prioritizes tasks both within each project and among projects for the research base team and makes informed decisions on study issues. • Maintains spreadsheets for clinical trials in progress used to track data time points• Maintains document control, database management, tracks project activities and team communication.• Develops standard operating procedures for all study management activities; monitors multiple research projects for conformity with standard operating procedures, ensuring compliance to protocol requirements and federal regulations. • Serves as a Lead Auditor, conducting on-site study audits at participating sites and ensures ongoing site compliance with study procedures as per NCI requirements.• Assesses and reports on study performance/benchmarking: enrollment, retention, and protocol deviations. • Strategizes with study chair in developing recruitment strategies for complex or difficult studies Data Management (10%):Works in tandem with the Lead Data Manager directing data management functions of the multisite, multi-project research base. Works with investigators, database programmers, information analysts, data clerks and biostatisticians in all aspects of data management activities, including database development, data collection procedures, data audit and database preparation for analysis. Specific duties include: • Develops and updates data collection SOPs as needed.• Coordinates all steps of data management, including auditing of subjects’ charts, generating queries and contacting coordinators for query responses• Monitors data entry for completeness, accuracy and timeliness.• Oversees the development of protocol-specific databases for data entry; works closely with database programmers to ensure accuracy, and privacy and confidentiality of all electronic data.• Assists programmers in maintaining database integrity• Works with the Biostatistician to interpret data collected
Performs other duties as needed (10%)
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.
Preferred: Knowledge of computer databases, spreadsheets and graphics packages. Strong managerial, research and communication skills.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled