Clinical Research Coordinator

Clinical Research Coordinator

Bethesda, MD

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.

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
• Assist with feasibility assessments for proposed clinical trials
• Support startup activities for new studies
• Coordinate participating sites for multi-center trials
• Monitor study progress and enrollment-related metrics
• 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

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: View email address on click.appcast.io

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.

Salary Range

$145,000 - $155,000 USD