Clinical Research Study Manager Jobs in Reston, VA

Job Family:

Travel Required:

Clearance Required:

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

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

About Guidehouse

Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.