Clinical Research Coordinator

Kelly; Bethesda (MD); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Paid time off & holidays

Transit benefit

Job summary

Kelly Government Solutions seeks an experienced Clinical Research Coordinator to support the NCI SOAR program in Bethesda, Maryland. You will coordinate oncology trials, manage participant recruitment, and ensure quality data in a fast-paced, regulated environment.

Responsibilities include regulatory submissions, informed consent, site monitoring, and ensuring protocol adherence with strong collaboration across teams. Strong organizational and communication skills are essential.

Qualifications

• Direct experience supporting oncology clinical trials and operations.
• Deep understanding of FDA regulations, ICH-GCP, and human subjects protections.
• Experience with EMR, CTMS, and EDC platforms for data capture and study management.

Responsibilities

• Coordinate multiple clinical studies from startup to closeout with strict timelines.
• Screen participants, schedule visits, assess eligibility, and ensure protocol adherence.
• Serve as the primary contact for participants, provide protocol education, and manage visit schedules.
• Assist with informed consent processes and regulatory submissions to IRBs.
• Maintain data integrity by validating CRFs and resolving queries with sponsors and monitors.
• Support site monitoring activities and ensure audit-ready study files.

Skills

Oncology experience

Regulatory knowledge

EMR/CTMS/EDC familiarity

Clinical procedures support

Strong communication

Education

Bachelor's degree in a related field

Tools

EMR

CTMS

EDC

Job description

Description 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly Government Solutions?

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world’s most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It’s just another way we make the job search work for you.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.