Supervisor, Clinical Research Data Team- Winship Cancer Institute

Emory University•Brookhaven, GA

About The Position

The Supervisor, Clinical Research Data Team (SCRDT) supports the research program within the Clinical Trials Office at Winship Cancer Institute of Emory University. The role oversees data activity for complex research trials and collaborates with clinical and regulatory teams to document and report study enrollment, treatment, and follow-up information in databases as required by research protocols. The SCRDT implements and conducts data management and compliance for multiple research projects, works closely with investigators, sponsors, and study teams, and provides day-to-day supervision, guidance, and training to Data Coordinator I and II staff. The position is responsible for clinical data management across industry, cooperative group, investigator-initiated, NCTN, and sponsor trials, including data quality, documentation, monitoring, audits, and regulatory compliance. It also supports the development and improvement of research information systems and maintains the accuracy, completeness, and confidentiality of research data.

Requirements

Bachelor's degree in a scientific, health-related, or business administration program, or an equivalent combination of education and experience.
Three years of clinical research data management experience, or equivalent combined education and experience.
Experience with electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS).
Complete required training, credentialing, and background verification, including clinical research orientation and training such as CITI and HIPAA, system training, and AHA BLS certification as applicable to job duties.
For employees whose responsibilities require access to EHC facilities, complete required health assessment, drug screening, immunizations including annual flu vaccine, competency validation, and other EHC requirements, with ongoing compliance.

Nice To Haves

Working knowledge of ICH/GCP guidelines, clinical research, clinical trials processes, and FDA regulations.
ACRP/SoCRA or equivalent certification, preferred within three years of hire.

Responsibilities

Implement and conduct data management and compliance for multiple research projects, coordinating with investigators, sponsors, and study teams.
Provide guidance, training, onboarding, quality assurance, and day-to-day supervision of Data Coordinator I and II staff.
Serve as a resource on clinical research and compliance for investigators and healthcare personnel involved in patient care at Winship Cancer Institute.
Develop clinical trial database data specifications and metrics to reduce data delinquencies and missing documents and improve data accuracy, query logic, and validation.
Conduct double-data entry and oversee quality management of data entry for NCTN, investigator-initiated, and sponsor clinical trials.
Create and maintain project data management documentation, including Data Management Plans.
Extract and monitor clinical trial data to identify issues or trends and report findings to Winship Clinical Trials Office leadership.
Ensure clinical trial data in EDC, OnCore, EPIC, and sponsor CTMS systems are suitable for statistical and interim review and database lock or freeze, including data reconciliation.
Manage data inspections and audits involving clinical trial monitors, FDA inspectors, NCTN auditors, quality management, data safety and monitoring committees, and Emory CTAC.
Ensure data system compliance with established national regulatory authority guidelines.
Manage clinical data activities, including creating and collecting source documents, completing case report forms, and tracking and reporting serious adverse events.
Review medical records and other patient information to extract data for assigned industry, cooperative group, and investigator-initiated research protocols.
Attend study team and protocol training meetings, complete required study training, and provide updates on data management activities, timelines, database locks, study requirements, and query management.
Provide ongoing education and updates to study team members and healthcare professionals regarding data-related protocol activities.
Liaise with sponsors and in-house monitors, schedule monitoring visits, and address monitoring report findings.
Lead preparation for and participation in quality-control audits; verify the accuracy, completeness, and confidentiality of research data and address findings.
Establish and maintain procedures and systems, including computerized databases, for research coordination and data management.
Support Winship's Informatics team in developing and improving research information systems.
Ensure compliance with departmental, institutional, and federal requirements, regulations, and policies; maintain controls for data accuracy, completeness, and confidentiality.
Maintain confidentiality standards for potential and enrolled patients and comply with federal Health Insurance requirements.
Order and maintain equipment and supplies for research protocols and support Data Coordinator I and II staff as needed.
Perform other duties as assigned.