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

Strength through Unity and Inclusion

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