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Senior Clinical Trials Data Coordinator
FoundationSenior Clinical Trials Data Coordinator supporting oncology clinical trials at City of Hope. Responsible for data collection, quality assurance, and timely data entry into EDC systems.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial data, ensuring compliance with FDA regulations and ICH/GCP guidelines, while effectively communicating with sponsors and maintaining data integrity throughout the study lifecycle.
Highest-signal resume keywords
Clinical Trial Management System (CTMS)Electronic Medical Record (EMR)Data Entry AccuracySOCRA CertificationOncology-Specific Research
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 Standards DevelopmentQuality Assurance ChecksData Capture BuildsExcel ProficiencySource Documentation Management
Soft Skills
Effective CommunicationProblem Resolution
Tools & Technologies
ERegulatory Systems
Certifications & Qualifications
SOCRA CertificationACRP Certification
Industry Keywords
FDA RegulationsICH/GCP GuidelinesALCOCA StandardsInvestigator Initiated Studies (IITs)Clinical Research
Tech Stack
Tools & technologiesElectronGoogle Cloud Platform
About the role
Key responsibilities & impact- Enters study data into EMR and CTMS within 3 days of the study visit
- Build and maintain data standards for all clinical trials
- Participate in discussions related to and assist in the creation of Electron Data Capture (EDC) builds for Investigator Initiated Studies (IITs)
- Reviews and resolves queries within 3 days of notification
- Support clinical trial studies from preparation through closeout
- Ensure source documentation and management of clinical study data is in accordance with FDA regulations, ICH/GCP guidelines and ALCOCA + standards
- Perform quality assurance checks to ensure the accuracy of data entry
- Communicates with sponsors to address any protocol issues related to quality of data entry
- Escalates non-compliant data collection and/or submission
- Participates in departmental required meetings and trainings
Requirements
What you’ll need- Bachelor’s degree in Science, Health or related field
- Minimum of 5-7 years research or relevant experience
- Experience with CTMS, EMR and eRegulatory Systems
- SOCRA or ACRP Certification within 2 years of employment
- Preferably three (3) years of oncology-specific research
- Experience using Excel
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development