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

Mount Sinai Health System•New York, NY

7d•Onsite

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About The Position

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

Requirements

HS Diploma
SPSS, REDCap, SAS, R for data management/analytical activities

Responsibilities

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