Clinical Research Coordinator

Guidehouse • Bethesda, MD

24d • $65,000 - $108,000 • Onsite

About The Position

We are seeking a Clinical Research Coordinator to provide comprehensive clinical research coordination services for oncology and cancer-related clinical trials conducted within the National Cancer Institute (NCI). This is a full-time, on-site role in Bethesda, MD.

Requirements

• Bachelor’s degree in nursing, health sciences, public health, clinical research, or related field
• Minimum of ONE (1) year of experience supporting clinical trials from startup through closeout.
• Experience supporting oncology clinical trials and clinical research operations.
• Knowledge of FDA regulations ICH-GCP, human subjects protection, and clinical trial methodology.
• Experience with electronic medical records, clinical trial management systems, and electronic data capture platforms.
• Must be able to obtain and maintain a Federal or DoD “public trust”; candidates must receive approved adjudication prior to onboarding with Guidehouse.

Nice To Haves

• Strong organizational and project coordination skills
• Effective communication skills
• Candidates with an active public trust or suitability are preferred.

Responsibilities

• Provide guidance and operational training to junior staff, trainees, students, and temporary personnel as requested by the Government.
• Coordinate multiple clinical research studies simultaneously.
• Assist with onboarding activities related to protocol operations and study procedures.
• Support continuity of operations and knowledge transfer efforts.
• Collaborate with data management personnel to ensure data quality and completeness.
• Collect, review, validate, extract, and enter research data into approved electronic systems for analysis, including data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Support informed consent activities for observational and interventional studies as authorized by the principal investigator (PI).
• Screen, recruit, pre-screen, and schedule research participants according to protocol requirements.
• Educate participants regarding protocol requirements, study procedures, investigational therapies, visit schedules, and participant responsibilities.
• Serve as a primary point of contact for study participants and families.
• Ensure protocol-required events are completed within protocol-defined visit windows; document participant encounters in the electronic medical record and other approved systems and maintain complete and accurate source documentation.
• Participate in quality improvement initiatives related to documentation practices.
• Monitor study participant’s progress and report adverse events.
• Assist with adverse event reporting and protocol deviation documentation.
• Assist with preparation and submission of regulatory documentation to Institutional Review Boards (IRBs), protocol support offices, sponsors, and regulatory authorities; track regulatory deadlines and submission requirements.
• Ensure study records remain inspection-ready and audit-ready by maintaining regulatory binders, study files, delegation-of-authority logs, and associated study documentation; support audit preparation and inspection readiness activities.
• Support compliance with federal regulations governing human subjects’ research.
• Help staff in the collection, development, and quality control of essential clinical research efforts.
• Ensure protocol conduct complies with National Cancer Institute (NCI), National Institutes of Health (NIH), Food and Drug Administration (FDA), International Council for Harmonization-Good Clinical Practice (ICH-GCP), and applicable regulatory requirements.
• Coordinate the receipt and distribution of study materials and maintain accountability records for study resources.
• Support clinical staff in developing, implementing, and maintaining clinical research data files and materials.

Benefits

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level