The Contractor shall provide personnel capable of supporting complex clinical research portfolios and ensuring efficient coordination among investigators, research teams, oversight offices, regulatory agencies, collaborating institutions, and other stakeholders involved in the conduct of clinical research. Requires a Master's degree, along with preferred certifications such as SOCRA, FAC-P/M, FAC-COR, PMP, or ACRP credentials. Experience with clinical trial management systems and research databases, technology transfer or clinical trial agreements, and supporting NIH, NCI, academic medical centers, or federally funded research programs is preferred.
Coordinate operational activities for clinical studies — 1
Assist with feasibility assessments for proposed clinical trials — 2
Support startup activities for new studies — 3
Coordinate participating sites for multi-center trials — 4
Monitor study progress and enrollment-related metrics — 5
Reviews, assesses and evaluates clinical trial design and feasibility
Provide comprehensive management and oversight of assigned clinical research portfolios
Develop and maintain project management plans for clinical research projects
Monitor project schedules, timelines, deliverables, dependencies, and milestones
Track portfolio performance metrics and report progress to leadership
Assist Branch Chiefs and Program Leadership in prioritization of research activities
Support portfolio planning and resource allocation efforts
Monitor project execution to ensure alignment with organizational objectives
Reviews, evaluates and analyzes clinical trial data and study information
Lead development and maintenance of project-specific work plans
Coordinate project initiation, planning, execution, monitoring, and closeout activities
Facilitate project meetings and maintain meeting documentation
Track action items and follow-up activities
Monitor project performance and identify potential barriers to success
Assist investigators and research teams in achieving project objectives
Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation
Develop risk mitigation and response plans
Monitor identified risks throughout the project lifecycle
Escalate significant issues to leadership as appropriate
Coordinate corrective actions and resolution activities
Identify operational, regulatory, financial, and programmatic risks
Assesses and supports meetings, clinical trial assessments and site visits
Monitor and coordinate activities associated with protocol development, protocol amendments, IRB submissions, regulatory submissions, continuing reviews, study activation activities, and clinical trial monitoring activities
Support preparation for audits, inspections, and monitoring visits
Coordinate activities among investigators, regulatory staff, data managers, and clinical teams
Monitor compliance-related milestones and deliverables
Facilitate timely submission of required regulatory documents
Formulates guiding principles and Standard Operating Procedures (SOPs), and prepares staff for clinical research
Facilitate communication among study stakeholders
Assist with development of project-specific budgets
Monitor expenditures and financial performance
Track project funding and resource utilization
Develop financial forecasts
Identify potential budgetary concerns and recommend corrective actions
Prepare financial status reports for leadership review
Serve as liaison between assigned research programs and the Office of the Clinical Director (OCD), NCI Technology Transfer Center, regulatory offices, collaborating institutions, industry partners, and other NIH and NCI organizations
Coordinate leadership briefings and status updates
Prepare communication materials and project summaries
Assist Government personnel with development of Statements of Work
Assist with technical evaluations and acquisition planning activities
Track contractor performance, deliverables, and invoice status
Monitor contract milestones and option periods
Support COR activities as requested
Support strategic planning initiatives
Analyze program performance and operational effectiveness
Develop recommendations for process improvements
Assist leadership with prioritization of future research initiatives
Support implementation of organizational best practices
