Job Family:
Clinical Trial Operations
Travel Required:
None
Clearance Required:
Ability to Obtain Public Trust
What You Will Do:
We are currently searching for Clinical Research Coordinator to provide comprehensive clinical research coordination services for oncology and related clinical trials conducted within Intramural Research Programs within the National Institutes of Health (NIH). This is a full-time, on-site opportunity in Bethesda, MD.
- Provide guidance and operational training to junior staff, trainees, students, and temporary personnel as requested by the Government.
- Assist with onboarding activities related to protocol operations and study procedures.
- Support continuity of operations and knowledge transfer efforts.
- Collect, review, validate, and enter research data into approved electronic systems.
- Collaborate with data management personnel to ensure data quality and completeness.
- Ensure protocol conduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatory requirements
- Ensure study records remain inspection-ready and audit-ready, support compliance with federal regulations governing human subjects research as well as audit preparation and inspection readiness activities.
- Assist with preparation and submission of regulatory documentation to Institutional Review Boards (IRBs), Protocol Support Offices, sponsors, and regulatory authorities
- Resolve sponsor, monitor, and data management queries.
- Collect, review, validate, and enter research data into approved electronic systems, maintain complete and accurate source documentation, perform routine data quality control activities,
- Verify case report forms (CRFs), ensure collection and maintenance of progress notes, laboratory reports, pathology reports, imaging reports and studies, and other source documentation
- Coordinate collection, processing, tracking, storage, and shipment of research specimens, ensure proper chain-of-custody documentation and specimen accountability, coordinate specimen shipments to designated laboratories and repositories, obtain pathology materials, slides, tissue blocks, and laboratory reports required by protocols, and coordinate receipt and processing of outside pathology samples.
- Ensure compliance with data management plans and quality standards, support maintenance of databases, tracking systems, and study metrics.
- Serve as a primary point of contact for study participants and families; respond to participant inquiries and provide ongoing study-related education. Monitor participant compliance with study requirements and protocol procedures
- Screen, recruit, pre-screen, and determine research participant eligibility according to protocol requirements.
- Ensure the protocol-required activities are scheduled and completed within the protocol-defined visit windows.
- Coordinate and track pharmacokinetic (PK), pharmacodynamic (PD), imaging, biomarker, quality-of-life (QoL), and patient-reported outcome (PRO) assessments.
- Support continuing review, annual review, protocol amendment, and study closure submissions by maintaining regulatory binders and study files, delegation-of-authority logs and associated study documentation, by obtaining required signatures and approvals from study personnel, and tracking regulatory deadlines and submission requirements.
- Assist with adverse event reporting and protocol deviation documentation.
- Assist with development and maintenance of study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication.
- Support protocol activation, implementation, conduct, and closeout activities.
- Coordinate protocol-specific procedures and operational requirements.
- Identify and resolve protocol implementation issues in collaboration with the PI and study team, monitor study progress and participant accrual, participate in multidisciplinary clinical rounds and study team meetings, assist investigators in evaluating participant responses to investigational therapies, coordinate protocol amendments and operational implementation of approved protocol changes, assist with development and maintenance of study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication.
- Maintain accountability records for study resources, maintain inventories of study supplies, kits, equipment, and research materials, track inventory levels and expiration dates, order study-related supplies and equipment as needed, coordinate receipt and distribution of study materials.
- Participate in quality improvement initiatives related to documentation practices.
What You Will Need:
- Bachelor’s degree in nursing, biological sciences, public health, health sciences, clinical research or related field
- Minimum TWO (2) years of oncology clinical trials and clinical research operations support experience.
- Must have experience with electronic medical records (EMR), clinical trial management systems (CTMS), and electronic data capture (EDC) platforms or similar systems.
- Demonstrated knowledge of FDA regulations, ICH-GCP, human subjects protections, and clinical trial methodology
- Experience supporting clinical trials from startup through closeout.
- 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, communication, and project coordination skills.
- Strong attention to detail.
- Good oral and written communication skills.
- Proficient in MS Office Suite.
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
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.
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