Full-Time

Research Data Coordinator Lead

Updated on 11/26/2024

Medical University of South Carolina

Medical University of South Carolina

Compensation Overview

$46.7k - $86.3kAnnually

Mid

Charleston, SC, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • A bachelor's degree and three years of relevant program experience.
Responsibilities
  • In collaboration with the Data Core Manager, this position will support the identification and implementation of new initiative to streamline and increase efficiencies of data management activities.
  • This position will help develop strategic plans for the creation of a centralized data management core within the CTO.
  • This may involve the creation and maintenance of new training and process guides for data management and implementation of corrective action plans related to data underperformance or deficiencies.
  • Participates in staff training and new employee orientation and education regarding data management.
  • Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits.
  • Will work closely with the Data Core Manager and Quality Assurance and Education unit to onboard new clinical operations staff to develop data management skills.
  • Will review data management performance metrics and proposed new initiatives to leadership.
  • Timely and accurately submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC.
  • Maintains subject research charts and submits data for assigned patient caseload.
  • Patient management will include multiple disease programs and protocols.
  • Protocol management will include NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC).
  • Interprets protocols, informed consents and case report forms to develop and use study related forms, data, calendars and documents according to accepted clinical trials professional standards.
  • Meticulous data management is required for assigned studies and patient caseload.
  • Chart abstraction, timely submission of data forms, retrieval of data (includes calling outside M.D.s and hospitals), admission records, clinic visits, and all source is required.
  • Maintenance of research subject records and case report forms is essential.
  • Case report submission may include QOL surveys, radiologic scans, reports and staging tests.
  • Proactively plan, prioritize, and manage responsibilities to ensure timely and accurate data submission to specified research bases.
  • Data submission is timely and accurate per the protocol, patient calendar, and source documents.
  • Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy.
  • Data submission will include query resolution, and adverse event and concomitant medication logs.
  • Ensures source documentation is located within patient research chart for source documentation verification.
  • Visit-specific CRFs are to be completed per sponsor requirements.
  • Timely and accurately submits Adverse Events and Serious Adverse Events to the NCI, sponsors, our IRB and DSMC per Federal guidelines and institutional policies.
  • Prepares and submits initial and follow up adverse events as required and until resolution of adverse events.
  • Responsible for completion of adverse event and concomitant tracking logs.
  • Coordinates the reporting of adverse events and serious adverse events based on the NCI Common Toxicity Criteria, (CTC) and protocol requirements.
  • Adverse events are submitted for multiple disease programs on multiple studies.
  • Data is submitted to various sponsors, research bases, FDA & the local IRB as per institutional policies.
  • Reporting timelines within the Clinical Trials Office, IRB and study sponsors are met for reporting.
  • Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe.
  • This includes external and internal serious adverse events, protocol deviations, correspondence from sponsor, or any other documents requiring review and or submission to IRB.
  • Additional non-regulatory reporting requirements would include submission of screening logs and database updates.
  • For any protocol deviations that are known, these will be reported to Regulatory within 7 business days of knowing of the deviation.
  • Baseline medical history, adverse events and concomitant medications are captured for all research subjects on multiple studies.
  • Successfully applies the oncology Adverse Event term utilizing the NCI CTC.
  • Adverse events tracking and concomitant medication tracking logs are maintained for research subjects on various studies.
  • Participates in staff training on NCI CTC adverse event reporting.
Medical University of South Carolina

Medical University of South Carolina

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