Clinical Research Coordinator

## Clinical Research CoordinatorApplylocations: US - MD, Bethesdatime type: Full timeposted on: Posted Todayjob requisition id: 42239**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 skillsThe 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* 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 #J-18808-Ljbffr