NCI Registry Operations Lead (CTRP/CTRO & ClinicalTrials.gov PRS)

CGI•Fairfax, VA

1d•Hybrid

About The Position

CGI Federal seeks a Key Personnel lead to manage end-to-end registry operations for NCI’s Clinical Trials Reporting Program (CTRP/CTRO) and ClinicalTrials.gov PRS account administration. The role ensures timely trial registration, updates, accrual reporting, results reporting, and compliance with NIH policy and the ClinicalTrials.gov Final Rule (42 CFR Part 11). The position is based in CGI Federal’s Fairfax, Virginia office, with a hybrid working model acceptable. The lead oversees PRS account administration and governance, CTRP/CTRO operations and data stewardship, results-reporting compliance, quality assurance, performance reporting, and training and stakeholder engagement. The role establishes operational procedures and service levels, monitors data quality and PRS quality-control feedback, drives corrective actions, and reports performance metrics to NCI stakeholders. The ideal candidate has direct NCI experience and documented compliance outcomes. CGI Federal offers eligible professionals benefits beginning on their first day of employment. Employment offers in the United States are contingent on successfully completing a background investigation, which may vary by assignment and security-clearance requirements.

Requirements

At least 5 years of direct experience operating NCI CTRP/CTRO workflows and making ClinicalTrials.gov PRS submissions.
Demonstrated compliance outcomes, supported by metrics such as reductions in overdue updates or results, PRS quality-control response cycle times, or reductions in major issues returned.
Deep knowledge of NIH policy on dissemination of clinical trial information and the ClinicalTrials.gov Final Rule (42 CFR Part 11).
Proven leadership of registry operations teams and cross-functional coordination with sponsors, principal investigators, and data managers.
Expertise in SOP development, process improvement, and KPI reporting.
Strong communication skills, including the ability to brief senior stakeholders and lead trainings.

Nice To Haves

Experience integrating CTRP with enterprise systems and analytics, such as dashboards or quality-assurance automation.
Familiarity with NCI CTEP/CCR processes and NCI terminology standards (EVS/NCIt).
Experience with audits, corrective and preventive actions (CAPAs), and continuous-improvement frameworks.
Prior support to NCI/NIH programs as a prime contractor or key subcontractor.

Responsibilities

Manage sponsor/Responsible Party PRS accounts, user roles, and workflow controls.
Establish and enforce SOPs and SLAs for trial registration, updates, and results submissions.
Oversee abstraction of new and amended trial records and manage biannual and ad hoc updates.
Manage accrual reporting processes and data quality checks.
Lead planning and execution of results submissions and monitor PRS quality-control review feedback.
Drive corrective actions to achieve zero overdue results and reduce quality-control cycle times.
Define quality assurance plans and implement automated checks and dashboards for data completeness and accuracy.
Report monthly KPIs, including timeliness, accuracy, and PRS quality-control outcomes, to NCI stakeholders.
Develop and deliver training, SOPs, and job aids for investigators, data managers, and CTRP users.
Coordinate across CTRO, CBIIT, and program offices to align processes and communications.