Clinical Research Coordinator

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.

• SOCRA Certification

• FAC-P/M Certification

• FAC-COR Certification

• PMP Certification

• Association of Clinical Research Professionals (ACRP)

   

• Health and Medical Administrative Services

• Nursing

   

• Experience with clinical trial management systems and research database

   

• Experience with technology transfer agreements, clinical trial agreements, cooperative research and development agreements, or related research partnerships

• Experience supporting NIH, NCI, academic medical centers, or federally funded research programs

   

• Monthly Activity Report — Monthly

• Portfolio Status Report — Monthly

• Risk Management Report — Monthly

• Financial Status Report — Monthly

• Regulatory Tracking Report — Monthly

• Strategic Planning Support Reports — Ad-Hoc

• Annual Program Summary Report — Yearly

• Final Contract Summary Report — Ad-Hoc

   

• 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