Manager Data Systems- Radiation Oncology – Union Square Full Time Days

Supervises and coordinates the collection, entry and retrieval of clinical and research data for the department

Protocol development activities: collaborate with investigators in all phases of protocol development.

  Develop investigator-initiated projects 

 Coordinate and communicate with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of clinical trial  Understand scientific terminology 

 Understand hospital, local, state, and federal regulatory requirements 

 Create protocol study documents (informed consent forms, case report forms, brochures, pamphlets, etc.) 

 Coordinate all aspects of protocol submission for research projects 

 Understand scientific pre-clinical and clinical data applied to the conduct of clinical trials  Collaborate with study team to ensure study feasibility

Regulatory activities: oversee the regulatory processes for projects.

 Prepare and submit protocol application for IRB review 

 Track protocol application status through RUTH, GCO and InfoEd systems 

 Respond to inquiries for clarification  Gather clinical and safety data needed for annual IRB review 

 Investigational New Drug (IND) Applications 

 Study budget as needed 

 Update and maintain clinical trial status on clinicaltrials.gov website 

 Maintain/distribute regulatory documents  Work with study sponsors 

 Prepare reports for various hospital and regulatory offices of research activities 

 Research Liaison 

 Provide assistance to residents, fellows and students in the application process 

 Log and track study team regulatory documents 

 Work in CTSU, Imedidata and other regulatory systems

Clinical Research Coordinator activities: project maintenance, planning and reporting.

 Hold Site Initiation Visits in preparation for study opening 

 Review/confirm subject eligibility 

 Work with the research team to facilitate the enrollment of research subjects 

 Perform central subject registration with CCTO and ONCORE. 

 Monitor patient timeline for protocol compliance 

 Track and alert all study team members of patient research appointments

 Identify/collaborate with PI to report Serious Adverse Events 

 Train research team members on subject registration, regulatory processes and procedures and protocol compliance 

 Serve as the resource for detailed information on all studies 

 Maintain electronic and hard copy files 

 Work with all phases of clinical trials (start up to conclusion)

Data Management/Analysis activities: create, manage and protect departmental research systems by organizing, storing, and analyzing data. 

 Data entry and maintenance (prospective vs retrospective) 

 Create databases 

 Data acquisition 

 Data Mining 

 Review and prepare data from various sources 

 Data Cleaning  Exploratory Data analysis 

 Data Visualization 

 Work with all levels of staff in data abstraction/form creation 

 Data validation  Proficient in the use of computer programs 

 Identify all relevant source documents for abstraction and recording 

 Other data management responsibilities as needed 

 SPSS, REDCap, SAS, R for data management/analytical activities 

 Work with team members in the IRB (RUTH submissions), InfoED/IDEATE, GCO, DFG, PRMC

HS Diploma