(ID: 2026-3936)

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 Clinical Research Coordinator will support oncology and cancer-related clinical trials within the NCI Intramural Research Program. The role includes coordinating studies from startup through closeout, supporting participant recruitment and follow-up, managing research data and regulatory records, coordinating specimens and assessments, and supporting participant safety and protocol compliance.

Responsibilities

• Coordinate multiple clinical studies, supporting protocol activation, implementation, amendments, study conduct, and closeout in collaboration with investigators and study teams.
• Screen, recruit, assess eligibility, and schedule participants according to protocol criteria; support informed consent activities as authorized by the principal investigator (PI).
• Serve as a primary contact for participants and families, explain study procedures and investigational therapies, monitor adherence, and conduct study and survival follow-up.
• Coordinate visits, procedures, laboratory testing, imaging, and ancillary services within protocol-defined visit windows.
• Coordinate pharmacokinetic (PK), pharmacodynamic (PD), biomarker, quality-of-life (QoL), and patient-reported outcome (PRO) assessments, including questionnaires and interviews.
• Collaborate with clinical staff on blood specimens, electrocardiograms (ECGs), vital signs, measurements, wearable device data, and other protocol-required assessments.
• Maintain accurate source documentation and electronic medical record (EMR) entries; obtain and review outside medical records, pathology materials, imaging studies, and reports.
• Coordinate research specimen collection, processing, tracking, storage, and shipment; maintain chain-of-custody documentation and specimen accountability.
• Collect, validate, and enter research data; verify case report forms (CRFs), resolve queries, and perform quality control with data management staff.
• Maintain databases, trackers, and study metrics; prepare enrollment, workload, and study reports and support interim analyses and final reporting.
• Prepare regulatory submissions, continuing reviews, amendments, and closure documentation; maintain regulatory binders, delegation-of-authority logs, signatures, approvals, and submission deadlines.
• Assist with adverse event reporting and protocol deviation documentation, and maintain records ready for audits and inspections.
• Coordinate monitoring visits, prepare source and regulatory records, respond to findings, and track corrective actions.
• Support participant safety, help investigators evaluate responses to investigational therapies, and participate in multidisciplinary rounds and study meetings.
• Develop and maintain study tools, calendars, worksheets, and workflow documents; identify and resolve implementation issues and support documentation quality improvements.
• Ensure study conduct complies with NCI, NIH, Food and Drug Administration (FDA), International Council for Harmonisation Good Clinical Practice (ICH-GCP), and applicable regulatory requirements.
• Maintain study supply and equipment inventories, monitor expiration dates, order materials, and track receipt, distribution, and accountability.
• Provide operational guidance and training to junior staff, trainees, students, and temporary personnel; support onboarding, continuity of operations, and knowledge transfer.

Required Qualifications

• Bachelor’s degree in nursing, biological sciences, public health, health sciences, clinical research, or a related field.
• Experience supporting oncology clinical trials and clinical research operations.
• Demonstrated experience supporting clinical trials from startup through closeout.
• Knowledge of FDA regulations, ICH-GCP, human subjects protections, and clinical trial methodology.
• Experience with electronic medical records, clinical trial management systems, and electronic data capture platforms.
• Strong organizational, communication, and project coordination skills.

Deliverables

• Provide enrollment and accrual reports, protocol activity status reports, regulatory tracking reports, and data quality and query resolution reports monthly.
• Maintain specimen tracking logs daily.
• Provide study supply inventory reports quarterly.
• Provide monitoring visit support documentation, study closeout documentation, and a final technical summary report on an ad hoc basis.

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: [email protected]

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.