Clinical Research Coordinator

Guidehouse•Bethesda, MD

5d•Onsite

About The Position

Guidehouse is seeking a Clinical Research Coordinator to provide comprehensive coordination services for oncology and related clinical trials conducted within Intramural Research Programs at the National Institutes of Health (NIH). This is a full-time, on-site opportunity in Bethesda, Maryland, with no travel required. The position requires the ability to obtain Public Trust clearance. The coordinator supports clinical trials from activation through closeout, including participant screening and recruitment, protocol implementation, data and regulatory documentation, specimen coordination, and study quality activities. The role works with investigators, study teams, data management personnel, participants and families, sponsors, monitors, laboratories, and regulatory offices to ensure studies are conducted in accordance with protocols and applicable requirements. The coordinator also supports junior staff and trainees through operational guidance and training as requested by the Government.

Requirements

Bachelor’s degree in nursing, biological sciences, public health, health sciences, clinical research, or a related field.
At least two years of oncology clinical trials and clinical research operations support experience.
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.
Ability to obtain and maintain a Federal or DoD Public Trust; approved adjudication is required before onboarding with Guidehouse.

Nice To Haves

Active Public Trust or suitability.
Strong organizational, communication, and project coordination skills.
Strong attention to detail.
Good oral and written communication skills.
Proficiency in Microsoft Office Suite.

Responsibilities

Provide operational guidance and training to junior staff, trainees, students, and temporary personnel as requested by the Government; assist with onboarding, continuity of operations, and knowledge transfer.
Support protocol activation, implementation, conduct, and closeout, and coordinate protocol-specific procedures and operational requirements.
Screen, pre-screen, recruit, and assess research participants for eligibility according to protocol requirements.
Serve as a primary point of contact for participants and families, respond to inquiries, provide study-related education, and monitor participant compliance with study requirements.
Schedule and track protocol-required activities within defined visit windows, including pharmacokinetic, pharmacodynamic, imaging, biomarker, quality-of-life, and patient-reported outcome assessments.
Collect, review, validate, and enter study data into approved electronic systems; maintain accurate source documentation and perform routine data quality checks.
Collaborate with data management personnel to ensure data quality and completeness; resolve sponsor, monitor, and data management queries; verify case report forms.
Collect and maintain progress notes, laboratory and pathology reports, imaging reports and studies, and other source documentation.
Coordinate collection, processing, tracking, storage, and shipment of research specimens; maintain chain-of-custody and specimen accountability documentation; coordinate laboratory and repository shipments and pathology materials.
Ensure protocol conduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatory requirements; maintain inspection-ready and audit-ready study records and support audit preparation and inspection readiness.
Assist with preparation and submission of regulatory documentation to Institutional Review Boards, Protocol Support Offices, sponsors, and regulatory authorities.
Support continuing and annual reviews, protocol amendments, and study closure submissions by maintaining regulatory binders, study files, delegation-of-authority logs, signatures, approvals, deadlines, and submission requirements.
Assist with adverse event reporting and protocol deviation documentation.
Ensure compliance with data management plans and quality standards; support databases, tracking systems, and study metrics.
Identify and resolve protocol implementation issues 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 and coordinate operational implementation of approved protocol changes.
Develop and maintain study tools, trackers, calendars, worksheets, and workflow documents that support protocol execution and team communication.
Maintain accountability records and inventories for study supplies, kits, equipment, and research materials; track levels and expiration dates, order supplies as needed, and coordinate receipt and distribution.
Participate in quality improvement initiatives related to documentation practices.

Benefits

Medical, prescription, dental, and vision insurance.
Personal and family sick time and company-paid holidays.
Parental leave.
401(k) retirement plan.
Group term life insurance and travel assistance.
Voluntary life and accidental death and dismemberment insurance.
Health Savings Account and health care and dependent care Flexible Spending Accounts.
Transit and parking commuter benefits.
Short-term and long-term disability insurance.
Tuition reimbursement, personal development, certifications, and learning opportunities.
Employee referral program.
Corporate-sponsored events and community outreach.
Care.com annual membership.
Employee Assistance Program.
Supplemental benefits through Corestream, including critical care, hospital indemnity, accident insurance, legal assistance, and identity theft protection.
Position may be eligible for a discretionary variable incentive bonus.