University of Rochester Health Project Coord - 224988 in Rochester, New York
Health Project Coord
School of Medicine & Dentistry
Full Time 40 hours Grade 053 Surgery-Cancer Control
8 AM-4:30 PM
Under the direction of the Clinical Trials Manager and principal investigators, with latitude for independent judgement, the Research Project Coordinator is responsible for coordinating the day-to-day operations of large, multi-site biomedical and/or social-behavioral clinical trials within the URCC NCORP Research Base. This position will serve as liaison between the Research Base and clinical research staff at off-site locations, including investigators, physicians, study coordinators, and clinic staff, in all phases of assigned clinical research protocols. Working collaboratively with the PI, multidisciplinary research teams, and clinical sites across the United States, plan and execute required aspects of each research project.
Responsibilities:Coordinate multiple high volume, multisite clinical research projects:
Serve as the primary contact for protocol and data-related questions and issues from off-site locations (typically 20-100) nationally
Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication
Train site research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting
Monitor studies regularly for conformity with standard operating procedures, and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations
Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly.
Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project
Develop and maintain workflow, records of research activities, and prepare periodic and ad hoc reports, as required by investigators and/or regulatory bodies.
Ensure all protocol timelines are met-patient, study, data
Ensure proper reporting of adverse events to PI and Research Base Administration
Attend and present updates at weekly study management team meetings
Manage complex, high volume study data for assigned projects:
Develop appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data
Receive and verify incoming data in multiple formats, i.e., REDCap, scannable paper forms, activity trackers, electronic cognitive assessments, heart rate monitors and audio recordings of treatment sessions
Oversee data entry, engage in data audit activities such as chart review; verify data received are complete, accurate and submitted in a timely manner
Analyze and suggest improvements in flow of information, error detection/correction, etc.,
Maintain database integrity; review and evaluate patient data for statistical analysis, work with biostatistics team to resolve any discrepancies or problems
Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events. Contributes meaningful information to enhance publications or grant applications
Assist Principal Investigator and study team in the development of protocols, data collection forms, training materials
Create patient instructions and calendars
Develop data tracking forms for new clinical trials
Determine supply requirements for new projects and order supplies
Review and edit protocols and data forms for new projects under development
Study agents, supplies and equipment:
Assist Investigational Drug Service in distribution of study agent to off-site locations
Design and build biospecimen collection kits
Receive requests for and ship study-specific drug, supplies and equipment (e.g., devices such as activity trackers, heart rate monitors TENS units, recording equipment, training materials, manuals) for active clinical trials
Maintain shipping logs and database, track expiring supplies and communicate with sites, replace with in-date supplies
Retrieve, log and store biospecimens received from off-site locations
Produce laboratory reports
Serve as site auditor, primarily reviewing selected patient cases to ensure compliance with protocol; assist Lead Auditor in compiling information gathered during the audit for the final report to the NCI
Provide coordinator support and backup for studies assigned to other Research Base coordinators as needed
Perform other duties and projects as assigned
Position requires a Bachelor's degree in health or social science field and one to three years of clinical trials experience or a combination of education and experience. Knowledge of computer databases, spreadsheets and statistics required along with excellent communication skills.
Preferred QualificationsExcellent verbal and writing skills are required. Knowledge of computer databases, word processing, spreadsheets and graphics packages are important.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled