Clinical Research Coordinator

Axle; Bethesda (MD); On-site; USD 145,000 - 155,000; Full time

Benefits offered by this job

Paid Time Off

401K match

Educational Benefits

Employee Referral Bonus

Healthcare FSA

Parking Reimbursement Account

Dependent Care Assistant Program

Transportation Reimbursement Account

Job summary

Axle is a bioscience and information technology company supporting NIH/NCI in Bethesda, MD, and offering translational research tools and data science applications. We seek a Clinical Research Coordinator to manage complex portfolios, collaborate with investigators, and ensure regulatory compliance.

Requires a Master’s degree with preferred certifications (SOCRA, FAC-P/M, FAC-COR, PMP, ACRP) and experience with CRT management systems and research databases.

Qualifications

• Master's degree required; certifications such as SOCRA, FAC-P/M, FAC-COR, PMP or ACRP preferred.
• Experience with clinical trial management systems and research databases preferred.
• Experience supporting NIH/NCI or federally funded research programs is advantageous.

Responsibilities

• 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.
• Develop and maintain project management plans for clinical research projects.
• Monitor project schedules, timelines, deliverables, dependencies, and milestones.
• Prepare communication materials and project summaries.

Skills

Clinical trial coordination

Regulatory compliance

Project management

Education

Master's degree

Tools

Clinical trial management systems

Research databases

Job description

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

• 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.

Responsibilities

• 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
• Review, assess and evaluate 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
• Review, evaluate and analyze 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
• Review, evaluate and recommend 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
• Assess and support 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
• Formulate guiding principles and Standard Operating Procedures (SOPs), and prepare 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
• 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
• Monthly Activity Report – Monthly
• Regulatory Tracking Report – Monthly
• Strategic Planning Support Reports – Ad‑Hoc
• Annual Program Summary Report – Yearly
• Final Contract Summary Report – Ad‑Hoc

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

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.

Equal Employment Opportunity Statement

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: [e-mail]

Salary Range

$145,000 - $155,000 USD