Supervisor, Clinical Research Data Team- Winship Cancer Institute

Emory•Atlanta, GA

19h

About The Position

The Supervisor, Clinical Research Data Team (SCRDT) supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. The role oversees data activity for complex research trials and collaborates with clinical and regulatory teams to document and report study patient enrollment, treatment, and follow-up information in databases specified by research protocols. The SCRDT oversees the implementation and conduct of data management and compliance across multiple research projects, working closely with institutional investigators, study sponsors, and study teams. The role supervises and guides Data Coordinator I and II staff, provides training and education to research and healthcare personnel, and supports accurate, complete, and confidential clinical trial data. The position also manages data quality, database readiness and reconciliation, monitoring visits, audits, regulatory compliance, and research data systems.

Requirements

Bachelor's degree in a scientific, health-related, or business administration program, and three years of clinical research data management experience, or an equivalent combination of education and experience.
Experience with electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS) is required.
Complete all required training, credentialing, and background verification, including clinical research orientation and training (e.g., CITI and HIPAA), system training, and AHA BLS certification as applicable to job duties.
If 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, the clinical trials process, 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, interacting with investigators, sponsors, and study teams.
Provide day-to-day supervision and oversight of Data Coordinator I and II staff, including guidance, onboarding, training, and quality assurance.
Develop clinical trial database specifications and metrics to reduce data delinquencies and missing documents and improve data accuracy, query logic, and validation.
Manage double-data entry and quality management 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, identify issues or trends, and report them to Winship CTO leadership.
Ensure clinical trial data in EDC, OnCore, EPIC, and sponsor CTMS systems are ready for statistical review, interim review, and final database lock, including data reconciliation.
Manage data inspections and audits involving clinical trial monitors, FDA inspectors, NCTN auditors, quality management, the data safety and monitoring committee, and Emory CTAC.
Follow established national regulatory authority guidelines and ensure data system compliance.
Manage clinical data activities, including creating and collecting source documents, completing case report forms, and tracking and reporting serious adverse events.
Review and analyze medical records and other patient information to extract data for assigned industry, cooperative group, and investigator-initiated research protocols.
Attend study team meetings and update study team members on data management activities, timelines, database locks, study requirements, and query management.
Provide ongoing education and updates to study team members and healthcare professionals on data-related protocol activities.
Liaise with sponsors and the in-house monitoring team, schedule monitoring visits, and address monitoring report findings.
Lead CRDC preparation for and participation in quality control audits, verify research data accuracy, completeness, and confidentiality, 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, and maintain controls for research 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.