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Supervisor, Clinical Research Data Team
Emory University. Oversee data activity of complex research trials within Winship Cancer Institute's Clinical Trials Office .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research data management, including proficiency in electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS). Ensures compliance with regulatory guidelines and provides training and oversight for data coordination roles.
Highest-signal resume keywords
Clinical Research Data ManagementElectronic Data Capture (EDC) SystemsClinical Trials Monitoring Systems (CTMS)ICH/GCP GuidelinesACRP/SoCRA Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ManagementQuality ManagementData ReconciliationData AnalysisDatabase Lock ProceduresData Specifications DevelopmentDouble-Data EntrySource Document ManagementPatient Questionnaire AnalysisCompliance Monitoring
Soft Skills
CollaborationTraining and MentoringCommunicationProblem-SolvingLeadership
Tools & Technologies
OnCoreEPICClinical Trial Management Systems (CTMS)Data Management PlansResearch Information Systems
Certifications & Qualifications
ACRP CertificationSoCRA CertificationAHA BLS Certification
Industry Keywords
Clinical TrialsFDA RegulationsICH GuidelinesResearch ComplianceData Safety Monitoring
About the role
Key responsibilities & impact- Oversee data activity of complex research trials within Winship Cancer Institute's Clinical Trials Office
- Collaborate with clinical and regulatory teams to document and report patient enrollment, treatment, and follow-up information in protocol-specified databases
- Implement and conduct data management and compliance for multiple research projects
- Interact with institutional investigators, study sponsors, and study teams
- Provide guidance and support training for Data Coordinator I and II positions
- Serve as a clinical research and compliance resource for investigators and healthcare personnel
- Supervise and provide day-to-day oversight to Data Coordinators I and II
- Develop clinical trial database data specifications and metrics to reduce data delinquencies, missing documents, and data accuracy issues
- Perform double-data entry and quality management for NCTN, investigator-initiated, and sponsor clinical trials
- Create and maintain Data Management Plans and related project documentation
- Extract and monitor clinical trial data to identify issues or trends and report findings to Winship CTO leadership
- Manage clinical trial data in EDC, OnCore, EPIC, and sponsor CTMS for statistical review, interim review, and final database lock, including data reconciliation
- Manage data inspections and audits with clinical trial monitors, FDA inspectors, NCTN auditors, quality management, data safety and monitoring committees, and Emory CTAC
- Ensure data system compliance with national regulatory authority guidelines
- Manage creation and collection of source documents, case report forms, and serious adverse event tracking and reporting
- Review and analyze medical records and patient questionnaires to extract research data for assigned protocols
- Attend study team and protocol-related training meetings; 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
- Provide onboarding, training, and quality assurance for CRDC I and II positions
- Liaise with sponsors and in-house monitoring teams, schedule monitoring visits, and address monitoring report findings
- Lead preparation for and participation in quality control audits; verify research data accuracy, completeness, and confidentiality
- Establish and maintain procedures and computerized database systems for research coordination and data management
- Support Winship's Informatics team in developing and improving research information systems
- Maintain compliance with departmental, institutional, federal, and regulatory requirements and policies
- Maintain controls for research data accuracy, completeness, and confidentiality
- Maintain confidentiality standards for potential and enrolled patients
- Order and maintain equipment and supplies for research protocols
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor's in a scientific, health related, or business administration program
- Three (3) years of clinical research data management experience or an equivalent combination of education and experience
- Experience in electronic data capture (EDC) systems required
- Experience in clinical trials monitoring systems (CTMS) required
- Working knowledge of ICH/GCP guidelines preferred
- Knowledge of clinical research, clinical trials process and FDA regulations preferred
- ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire
- Completion of all required training, credentialing, and background verification
- Completion of clinical research orientation and training (e.g., CITI, HIPAA)
- System training
- AHA BLS certification as applicable to job duties
- Employees requiring access to EHC facilities must complete health assessment, drug screening, immunization requirements, competency validation, and other EHC requirements
- Ongoing compliance with applicable employment requirements
Benefits
Comp & perks- Regular full-time employment
- Equal opportunity employment
- Reasonable accommodations for qualified individuals with disabilities
- Required training, credentialing, and background verification provided/required as part of employment
- Clinical research orientation and training (e.g., CITI, HIPAA)
- System training
- AHA BLS certification as applicable to job duties
- Health assessment, drug screening, immunization requirements including annual flu vaccine, competency validation, and other EHC requirements as applicable