Description
(ID: 2026-2878)
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible
Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Position Overview
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.
Additional Qualifications
Certifications & Licenses
SOCRA Certification
FAC-P/M Certification
FAC-COR Certification
PMP Certification
Association of Clinical Research Professionals (ACRP)
Field of Study
Health and Medical Administrative Services
Nursing
Software
Experience with clinical trial management systems and research database
Skills
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
Deliverables
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
Statement of Work Details
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 le
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