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NCI Registry Operations Lead (CTRP/CTRO & ClinicalTrials.gov PRS) Category: Analytics and Emerging Digital Technologies
Main location: United States, Virginia, Fairfax
Position ID:J1126-0595
Employment Type: Full Time
Position Description: CGI Federal seeks a Key Personnel lead to manage end to end registry operations spanning NCI's Clinical Trials Reporting Program (CTRP/CTRO) and ClinicalTrials.gov (PRS) account administration, ensuring timely registration, updates, accrual reporting, results reporting, and compliance with NIH policy and the ClinicalTrials.gov Final Rule (42 CFR Part 11). The ideal candidate has direct NCI experience with documented compliance outcomes.
***This position is located in our Fairfax, VA office; however, a hybrid working model is acceptable***
Your future duties and responsibilities: . PRS account administration and governance . Manage sponsor/Responsible Party PRS accounts, user roles, and workflow controls . Establish and enforce SOPs and SLAs for registration, updates, and results submissions
. CTRP/CTRO operations and data stewardship . Oversee abstraction of new/amended trial records; manage biannual and ad hoc updates . Manage accrual reporting processes and data quality checks
. Results reporting compliance . Lead planning and execution for results submissions; monitor PRS QC review feedback . Drive corrective actions to achieve zero overdue results and reduced QC cycle times
. Continuous quality assurance and performance reporting . Define QA plans; implement automated checks and dashboards for data completeness/accuracy . Report monthly KPIs (e.g., timeliness, accuracy, PRS QC outcomes) to NCI stakeholders
. Training and stakeholder engagement . 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
Required qualifications to be successful in this role: . 5+ years direct experience operating NCI CTRP/CTRO workflows and ClinicalTrials.gov PRS submissions
. Demonstrated compliance outcomes: include metrics such as: . X% reduction in overdue updates/results . Median PRS QC response cycle time of X days . X% decrease in PRS major issues returned (or zero major issues for last X submissions)
. Deep knowledge of NIH policy on dissemination of clinical trial information and ClinicalTrials.gov Final Rule (42 CFR Part 11)
. Proven leadership of registry operations teams and cross functional coordination with sponsors, PIs, and data managers
. Expertise in SOP development, process improvement, and KPI reporting
. Strong communication skills; ability to brief senior stakeholders and lead trainings
Desired qualifications/non essential skills required:
. Experience integrating CTRP with enterprise systems and analytics (e.g., dashboards, QA automation)
. Familiarity with NCI CTEP/CCR processes and NCI terminology standards (EVS/NCIt)
. Experience with audits, CAPAs, and continuous improvement frameworks
. Prior support to NCI/NIH programs as prime or key subcontractor
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $91,800.00 $180,700.00.
CGI Federal's benefits are offered to eligible professionals on their first day of employment to include:
. Competitive compensation
. Comprehensive insurance options
. Matching contributions through the 401(k) plan and the share purchase plan
. Paid time off for vacation, holidays, and sick time
. Paid parental leave
. Learning opportunities and tuition assistance
. Wellness and Well being programs
#CGIFederalJob
Skills: - Clinical Workflows
- English
- PMI Project Management Prof
- Project Management
- Quality assurance
- Data Engineering
- Data Engineering
- Government Health Agencies
