Kelly Government Solutions is seeking an experienced, high-caliber Clinical Research Coordinator to support the Scientific, Operations and Administrative Resources (SOAR) program at the National Cancer Institute (NCI). In this role, you will be embedded directly within the NCI Intramural Research Program, providing comprehensive, autonomous clinical coordination for high-impact oncology and cancer-related clinical trials.

This position offers a stable, long-term contract framework supporting a critical mission to deliver high-quality clinical research in a safe, cutting-edge patient care environment.

Key Responsibilities

Study Coordination & Participant Management

• Manage Operations: Coordinate multiple clinical research studies simultaneously from study startup through final closeout.
  

• Recruitment & Screening: Screen, pre-screen, and schedule research participants; assess eligibility based on strict protocol inclusion/exclusion criteria.
  

• Patient Advocacy: Serve as the primary operational point of contact for study participants and families, providing education on protocols, investigational therapies, and visit schedules.
  

• Informed Consent: Support informed consent activities for observational and interventional trials as authorized by the Principal Investigator (PI).
  

• Timeline Management: Coordinate protocol-required visits, procedures, laboratory testing, and ancillary services, ensuring all events occur within strict protocol-defined windows.
  

Data Management & Quality Control

• Data Integrity: Collect, review, validate, and enter complex clinical research data into electronic systems, verifying case report forms (CRFs) against original source documentation.
  

• Query Resolution: Actively resolve sponsor, monitor, and data management queries to ensure total data completeness.
  

• Specialized Tracking: Coordinate and track pharmacokinetic (PK), pharmacodynamic (PD), biomarker, imaging, and patient-reported outcome (PRO) assessments.
  

• Specimen & Imaging Logistics: Coordinate the collection, processing, chain-of-custody tracking, storage, and shipment of research specimens and pathology materials.
  

Regulatory & Compliance Support

• IRB Submissions: Assist with the preparation and submission of regulatory documentation to Institutional Review Boards (IRBs), protocol support offices, and regulatory authorities.
  

• Safety Reporting: Assist with documenting and reporting adverse events (AEs) and protocol deviations.
  

• Audit Readiness: Maintain regulatory binders, delegation-of-authority logs, and study files to ensure records remain perpetually inspection- and audit-ready.
  

• Site Monitoring: Serve as the primary operational contact during monitoring visits, facilitating sponsor, CRO, internal, and external monitoring activities.
  

Position Requirements

Education & Experience

• Minimum Education: Bachelor’s degree in Nursing, Biological Sciences, Public Health, Health Sciences, Clinical Research, or a closely related field.
  

• Resume Limit: Maximized to 3 pages or fewer.
  

Required Skills & Qualifications

• Oncology Expertise: Direct experience supporting oncology clinical trials and clinical research operations.
  

• Regulatory Knowledge: Deep understanding of FDA regulations, ICH-GCP guidelines, human subjects protections, and clinical trial methodology.
  

• Systems Familiarity: Experience utilizing electronic medical records (EMR), clinical trial management systems (CTMS), and electronic data capture (EDC) platforms.
  

• Clinical Procedures: Proficiency collaborating with clinical staff to facilitate the collection of PK/PD samples, blood specimens, ECGs, and vital signs.
  

• Soft Skills: Exceptional organizational, multi-tasking, communication, and interdisciplinary collaboration skills.
  

Why Kelly Government Solutions?
As a global staffing leader for more than 20 years at the National Institutes of Health (NIH), Kelly Government Solutions connects specialized scientific professionals with the country’s elite federal research facilities. We offer competitive compensation, comprehensive benefits packages, and dedicated, expert onboarding infrastructure to support your career growth behind the scenes while you focus on advancing cancer research.

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