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

Compensation Statement

The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $59,267.00 - $88,900.00 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Non-Bargaining Unit, BVE - Radiology Oncology - USD, Union Square - Downtown