Protocol Data Analyst I at EDJ Associates,

Washington, District of Columbia, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jun, 26

Salary

0.0

Posted On

09 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Analysis, Clinical Trials, Data Abstraction, NCI Thesaurus, Biomarker Coding, Accrual Processing, Data Curation, SOP Adherence, GCP Guidelines, Issue Resolution, ServiceNow, Protocol Review, Data Integrity, Technical Writing, Regulatory, Attention To Detail

Industry

Business Consulting and Services

Description

Protocol Data Analyst I Department: Research Employment Type: Full Time Location: National Institue of Health - Washington DC Area Description 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

Responsibilities

The Protocol Data Analyst I processes new trial and amendment submissions within a 10-business-day SLA, which involves coding clinical trials using NCI Thesaurus and abstracting scientific data. This role also supports data curation in the CTRP database and responds to user inquiries via the ServiceNow ticketing system.