Research Data Associate

NYU Langone Health•New York, NY

About The Position

The Research Data Associate coordinates basic-level cancer clinical research studies at the Laura and Isaac Perlmutter Cancer Center. The role performs participant enrollment and data entry and works under general supervision, interfacing with Principal Investigators, clinical study team members, regulatory and quality assurance specialists, financial coordinators, study monitors, and service-rendering departments in support of cancer clinical trials. The associate supports human-subjects research, including study data entry and query resolution, study-visit logging, pathology and tissue requests, imaging submissions, monitoring-visit coordination, vial assignments, eligibility review and participant registration, and reporting of serious adverse events and other reportable events. The role also collects and analyzes research data, updates databases and case report forms, assists with eligibility screening and follow-up assessments, and prepares preliminary reports for review by the Principal Investigator. The associate develops knowledge of Good Clinical Practice, applicable regulations, institutional research policies, oncology terminology, and the Electronic Medical Record.

Requirements

  • Bachelor's degree or equivalent in business administration, health care administration, or a related field.
  • At least two years of progressively responsible project coordination experience, preferably in a research setting.
  • Proficiency with Microsoft Office applications, including Word, Excel, Access, PowerPoint, and Outlook, and familiarity with Internet applications.
  • Effective oral, written, communication, and interpersonal skills.
  • Ability to interface effectively with all levels of management and communicate effectively with internal and external customers.
  • Ability to work both within a team and independently, including making decisions independently.
  • Commitment to continuous learning as required by department administration.
  • Ability to operate research-related equipment.
  • Time-management skills and ability to multitask.
  • Ability to identify, analyze, and solve problems, and to work well under pressure.
  • Ability to communicate effectively with all levels of the organization.

Nice To Haves

  • Bachelor's degree.

Responsibilities

  • Demonstrate knowledge of the organization's Core Values and incorporate them into work.
  • Enter study data and resolve queries for assigned simple studies, ensuring data entry within one week or less of the last study visit.
  • Log study visits in the Clinical Research Management System (CRMS) as they occur to support timely sponsor billing.
  • Request pathology reports and tissue acquisition required by study protocols.
  • Coordinate imaging submissions with the Department of Radiology.
  • Schedule monitoring visits and coordinate with study monitors, the CTO Administrative Assistant, and Vornado Realty Trust; request charts and Electronic Medical Record access, document visits in the Data Coordination Unit SharePoint, and notify the Business Operations Unit of monitor changes or additions for billing purposes.
  • Perform vial assignments and communicate with the study team and investigational pharmacy.
  • Assist with eligibility review and participant registration with study sponsors and in CRMS.
  • Coordinate submission of serious adverse events and other reportable events to the Data and Safety Monitoring Committee when applicable, study sponsors, and the Institutional Review Board.
  • Collect patient information for research projects, including information from patient charts and outside physicians' offices, and use tools such as calendars, schedules, and tracking logs to facilitate data collection.
  • Update databases and case report forms, and assist with medical-history review and screening procedures to confirm protocol eligibility.
  • Report adverse events and serious adverse events to applicable agencies.
  • Attend research and committee meetings, including DMG Research Meetings and Data and Safety Monitoring Committee Meetings.
  • Develop the ability to navigate and independently extract information from the Electronic Medical Record, and assist CCU staff with follow-up calendars to ensure protocol-required survival assessments are completed.
  • Gather and compile data, assist with consolidation and analysis for sponsoring and regulatory agencies, provide study-progress reports as needed, conduct primary analysis, and prepare databases and preliminary measurement reports for Principal Investigator review.
  • Participate in special projects and perform other duties as required.

Benefits

  • Comprehensive benefits and wellness package.
  • Financial security benefits.
  • Generous time-off program.
  • Employee resource groups for peer support.
  • Employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being.
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