Clinical Research Coordinator

Axle • Bethesda, MD

5d • $145,000 - $155,000 • Onsite

About The Position

Axle is seeking a Clinical Research Coordinator to support the National Cancer Institute (NCI) at the National Institutes of Health (NIH) in Bethesda, Maryland. The position supports oncology and cancer-related clinical trials within the NCI Intramural Research Program, coordinating studies from startup through closeout. Work includes participant recruitment and follow-up, research data and regulatory record management, specimen and assessment coordination, participant safety, and protocol compliance.

The coordinator works with investigators, study teams, clinical staff, data management staff, participants, and families. The role also includes preparing study reports and regulatory submissions, supporting monitoring visits and audits, maintaining study supplies and tools, and providing operational guidance and training to junior staff, trainees, students, and temporary personnel. Study conduct must comply with applicable NCI, NIH, FDA, ICH-GCP, and other regulatory requirements.

Requirements

• 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.

Responsibilities

• Coordinate multiple clinical studies, including protocol activation, implementation, amendments, study conduct, and closeout, in collaboration with investigators and study teams.
• Screen and recruit participants, assess eligibility, schedule participants according to protocol criteria, and support informed consent activities as authorized by the principal investigator.
• 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, pharmacodynamic, biomarker, quality-of-life, and patient-reported outcome assessments, including questionnaires and interviews.
• Collaborate with clinical staff on blood specimens, electrocardiograms, vital signs, measurements, wearable-device data, and other protocol-required assessments.
• Maintain accurate source documentation and electronic medical record 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, 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, FDA, 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.
• Provide monthly enrollment and accrual reports, protocol activity status reports, regulatory tracking reports, and data quality and query resolution reports.
• 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.

Benefits

• 100% medical, dental, and vision coverage for employees
• Paid time off and paid holidays
• 401(k) match up to 5%
• Educational benefits for career growth
• Employee referral bonus
• Flexible spending accounts, including healthcare FSA, parking reimbursement account, dependent care assistance program, and transportation reimbursement account

What This Job Offers

• Job Type: Full-time