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
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
