Associate, Research Data - Clinical Trials - Mineola
About The Position
NYU Langone Hospital—Long Island is seeking an Associate, Research Data to provide direct data entry and central study subject registration support for investigators conducting cancer clinical trials. The role involves extracting medical information from electronic medical records and paper source documents, entering that information into study-specific Case Report Form (CRF) systems, and resolving data queries in collaboration with investigators and research nurses. The Associate also ensures central subject registration captures required fields in accordance with government reporting requirements and Perlmutter Cancer Center Clinical Trials Office policies. The position schedules and hosts study monitoring visits.
Requirements
- Bachelor's degree.
- Knowledge of MS Office suites, databases, spreadsheets, graphic applications, and communications applications.
- Exceptional communication, analytical, presentation, and time-management skills.
- Ability to work as part of a team.
- Ability to communicate effectively with all levels of the organization.
Nice To Haves
- Bachelor's degree in biological sciences or another health-related field.
- One year of experience in a research setting, such as a laboratory or other research environment.
- General understanding of medical terminology.
Responsibilities
- Perform other duties as assigned.
- Complete data entry for assigned studies; collect, compile, and enter clinical and non-clinical data into databases and case report forms; extract data for publications or collect data from outside physicians' offices; and provide quality data to sponsors in a timely manner.
- Log study visits in the Clinical Research Management System (CRMS) for billing in real time as case report forms are completed for each visit.
- Schedule external monitors, including managing Vornado, DCU SharePoint, Epic access requests, and desk space requests; host monitoring visits; assess compliance; and perform source verification on assigned cancer clinical trials.
- Assist the Research Nurse with study treatment vial assignments as needed using Interactive Voice Response Systems (IVRS).
- Assist with processing Serious Adverse Event (SAE) or Reportable Event submissions, coordinating with study investigators, clinic staff, sponsors, and regulatory personnel.
- Coordinate central uploads of imaging and central submissions of pathology specimens and reports.
- Review eligibility packets from the Investigator and Research Nurse to ensure informed consent and supporting documentation are complete before subject registration in CRMS and enrollment with the study sponsor; communicate registration completion to study team members and investigators.
- Perform quality assurance checks of source documentation and help resolve discrepancies with the Principal Investigator and Research Coordinators.
- Assist Research Coordinators in maintaining a follow-up calendar and ensuring survival follow-up assessments are completed according to protocol.
- Manage data queries in collaboration with investigators and research nurses.
- Ensure central subject registration captures required fields in accordance with government reporting requirements and Clinical Trials Office policies.
Benefits
- Comprehensive benefits and wellness package.
- Financial security benefits.
- Generous time-off program.
- Employee resource groups for peer support.
- Holistic employee wellness program addressing physical, mental, nutritional, sleep, social, financial, and preventive care.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
