Clinical Research Coordinator

Axle • Bethesda, MD

5d

About The Position

Axle is seeking a Clinical Research Coordinator to support the National Cancer Institute (NCI) Intramural Research Program at the National Institutes of Health (NIH) in Bethesda, Maryland. The coordinator will support oncology and cancer-related clinical trials, coordinating studies from startup through closeout. The role includes participant recruitment and follow-up; research data and regulatory record management; coordination of specimens, visits, procedures, and assessments; and support for participant safety and protocol compliance.

The position works with investigators, study teams, clinical staff, data management staff, participants, and families. It also supports monitoring visits, reporting, study supplies, operational guidance, and training for junior staff, trainees, students, and temporary personnel. Study conduct must comply with NCI, NIH, FDA, ICH-GCP, and other applicable requirements. The role provides monthly enrollment, protocol activity, regulatory tracking, and data quality reports; daily specimen tracking logs; quarterly inventory reports; and monitoring, closeout, and technical summary documentation on an ad hoc basis.

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 from protocol activation and implementation through amendments, study conduct, and closeout in collaboration with investigators and study teams.
• Screen and recruit participants, assess eligibility, schedule participants, 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 study 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, ECGs, vital signs, measurements, wearable device data, and other protocol-required assessments.
• Maintain accurate source documentation and EMR entries; obtain and review outside medical records, pathology materials, imaging studies, and reports.
• Coordinate research specimen collection, processing, tracking, storage, and shipment, and 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 and 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