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 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 $59267.00 - $88900.00 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