Clinical Research Coordinator

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

Benefits offered by this job

Paid time off

401K match up to 5%

Educational benefits for career growth

Employee referral bonus

Flexible spending accounts: healthcare

Job summary

Axle, a bioscience and IT company, seeks a Clinical Research Coordinator to support the National Cancer Institute at NIH in Bethesda, MD. The contractor will coordinate clinical study activities, liaise with investigators and regulators, and ensure compliant trial execution.

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

Qualifications

• Master's degree required; certifications such as SOCRA, FAC-P/M, FAC-COR, PMP, or ACRP preferred.

Responsibilities

• Coordinate operational activities for clinical studies.
• Assist feasibility assessments for proposed trials.
• Support startup activities for new studies.
• Coordinate participating sites for multi-center trials.
• Monitor study progress and enrollment metrics.
• Provide comprehensive management of assigned clinical research portfolios.
• Develop and maintain project management plans for clinical research projects.
• Track portfolio performance and report progress to leadership.

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.

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

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

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

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: [e-mail]

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 USD - $155,000 USD