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

Mount Sinai Health System•New York, NY

7d•$59,267 - $88,900•Onsite

About The Position

The Manager Data Systems - Radiation Oncology – Union Square Full Time Days position supervises and coordinates the collection, entry, and retrieval of clinical and research data for the department. This role involves protocol development, regulatory activities, clinical research coordination, and data management/analysis. The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence and is dedicated to delivering outstanding patient care. As part of this commitment, they encourage participation in creating a culture of fair access to opportunities, inclusive practices, and support for individual success. Leaders at Mount Sinai are committed to fostering a workplace where employees feel valued, respected, and empowered to grow, driving positive change and improving well-being.

Requirements

HS Diploma

Responsibilities

Collaborate with investigators in all phases of protocol development, including developing investigator-initiated projects.
Coordinate and communicate with investigators and research team members to aid in study development and oversight.
Understand scientific terminology, hospital, local, state, and federal regulatory requirements.
Create protocol study documents such as informed consent forms, case report forms, brochures, and pamphlets.
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 the study team to ensure study feasibility.
Oversee the regulatory processes for projects, including preparing and submitting protocol applications for IRB review.
Track protocol application status through RUTH, GCO, and InfoEd systems.
Respond to inquiries for clarification and gather clinical and safety data needed for annual IRB review.
Manage Investigational New Drug (IND) Applications and study budgets as needed.
Update and maintain clinical trial status on the clinicaltrials.gov website.
Maintain and distribute regulatory documents and work with study sponsors.
Prepare reports for various hospital and regulatory offices of research activities.
Serve as a Research Liaison and provide assistance to residents, fellows, and students in the application process.
Log and track study team regulatory documents and work in CTSU, Imedidata, and other regulatory systems.
Manage project maintenance, planning, and reporting, including holding Site Initiation Visits.
Review and confirm subject eligibility and facilitate the enrollment of research subjects with the research team.
Perform central subject registration with CCTO and ONCORE.
Monitor patient timelines for protocol compliance and track/alert study team members of patient research appointments.
Identify and collaborate with the PI to report Serious Adverse Events.
Train research team members on subject registration, regulatory processes, procedures, and protocol compliance.
Serve as the resource for detailed information on all studies and maintain electronic and hard copy files.
Work with all phases of clinical trials from start-up to conclusion.
Create, manage, and protect departmental research systems by organizing, storing, and analyzing data.
Perform data entry and maintenance (prospective vs retrospective), create databases, and manage data acquisition.
Conduct data mining, review and prepare data from various sources, and perform data cleaning.
Conduct exploratory data analysis and data visualization.
Work with all levels of staff in data abstraction/form creation and data validation.
Ensure proficiency in the use of computer programs and identify all relevant source documents for abstraction and recording.
Perform other data management responsibilities as needed.
Utilize SPSS, REDCap, SAS, R for data management/analytical activities.
Collaborate with team members in the IRB (RUTH submissions), InfoED/IDEATE, GCO, DFG, PRMC.