The Role
The Protocol Data Analyst I processes clinical trial submissions, abstracts data, codes trials, and ensures data quality within set timelines while following established guidelines.
Summary Generated by Built In
CONTINGENT HIRE NOTICE: This position is a contingent hire. Employment is contingent upon EDJ Associates, Inc. receiving a contract award. This position is performed primarily on-site at NIH headquarters in Bethesda, Maryland. Applicants must be able to obtain and maintain a security clearance from the federal government.
The Protocol Data Analyst I is part of the core abstraction team within the CTRO, responsible for processing new trial and amendment submissions within the 10-business-day service-level agreement (SLA). This role codes clinical trials using the NCI Thesaurus, abstracts biomarkers, processes accrual data, and supports person and organization curation in the Clinical Trials Reporting Program (CTRP) database.
Key Responsibilities
• Process new trial registrations and amendments within the 10-business-day SLA, including reviewing submissions and notifying submitters of acceptance, rejection, or on-hold status.
• Abstract clinical trial administrative and scientific data following established SOPs.
• Code trials using the NCI Thesaurus terminology for disease/condition, intervention, biomarker, and anatomic site data elements.
• Process and validate accrual submissions, including verifying requestor associations and trial registration status.
• Support person and organization curation to ensure data consistency and quality.
• Review header information, protocol documents, and administrative data elements for each trial.
• Follow Good Clinical Practices (GCP) data-handling procedures and guidelines.
• Respond to user inquiries and assist with issue resolution through the ServiceNow ticketing system.
• Participate in the review of clinical research protocols, reports, and statistical analysis plans.
• Support quality assurance and data integrity activities as directed.
Skills, Knowledge and Expertise
• Minimum of one (1) year of experience working in a clinical environment, including medical and regulatory technical writing/editing.
• Knowledge of drug and disease terminology.
• Strong attention to detail and commitment to data accuracy.
• Ability to follow standard operating procedures and work within defined timelines.
• Familiarity with GCP guidelines preferred.
• Ability to obtain and maintain a Level 1 (Non-Sensitive) NACI background investigation.
Tools and Technologies:
• Microsoft Office Suite (Word, Excel, PowerPoint)
• CTRP Registration and Protocol Abstraction systems
• NCI Thesaurus / Enterprise Vocabulary Services (EVS)
• ServiceNow or similar ticketing systems
About
We are a woman-owned small business providing management consulting and technical services based in Herndon, Virginia. Founded in 1999, we’ve established a solid track record of success in the planning, design, and implementation of a wide range of projects in the areas of administrative and peer review support, event planning, logistics management, and information management. Our clients include Federal agencies, state and local units of government, private companies, and nonprofit organizations.
Skills Required
- Minimum of one year of experience working in a clinical environment
- Knowledge of drug and disease terminology
- Strong attention to detail and commitment to data accuracy
- Ability to follow standard operating procedures
- Familiarity with GCP guidelines
- Ability to obtain and maintain a Level 1 NACI background investigation
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The Company
What We Do
EDJ Associates, Inc. is a woman-owned small business providing professional and technical services, including consulting, digital, design, and communications support, to federal, private, and nonprofit clients. They specialize in areas such as clinical trial support, data management, and event planning.
