Clinical Research Coordinator

Job Family : Clinical Trial Operations Travel Required : None Clearance Required : Ability to Obtain Public Trust What You Will Do : 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. 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. What You Will Need : 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. Candidates with an active public trust or suitability are preferred. What Would Be Nice To Have : Strong organizational and project coordination skills Effective communication skills The annual salary range for this position is $65,000.00-$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs. What We Offer: Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: 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 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 About Guidehouse Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. 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