Clinical Research Coordinator

Guidehouse•Bethesda, MD

6d•$65,000 - $108,000•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. This is a full-time, on-site position in Bethesda, Maryland, with no travel required. The role supports clinical trials from activation through closeout and helps ensure their operational, regulatory, data-management, and participant-care requirements are met. The coordinator works with investigators, study teams, participants and families, data-management personnel, sponsors, monitors, laboratories, and regulatory bodies. Responsibilities include participant screening and enrollment, coordinating protocol visits and assessments, maintaining source documents and study records, handling research specimens, supporting regulatory submissions and inspection readiness, and monitoring study progress and data quality. The role also supports junior staff through operational guidance and training, and contributes to continuity of operations and quality-improvement efforts.

Requirements

Bachelor’s degree in nursing, biological sciences, public health, health sciences, clinical research, or a related field.
At least 2 years of oncology clinical-trial 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.

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 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, and support continuity of operations and knowledge transfer.
Collect, review, validate, and enter research data into approved electronic systems; maintain complete and accurate source documentation and perform routine data quality control.
Collaborate with data-management personnel to ensure data quality and completeness, resolve sponsor, monitor, and data-management queries, and support compliance with data-management plans and quality standards.
Ensure protocol conduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatory requirements.
Maintain inspection-ready and audit-ready study records; support compliance with federal human-subjects research regulations, audit preparation, and inspection-readiness activities.
Assist with preparation and submission of regulatory documentation to Institutional Review Boards, Protocol Support Offices, sponsors, and regulatory authorities.
Verify case report forms and ensure collection and maintenance of 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 documentation and specimen accountability; coordinate shipments and receipt and processing of outside pathology samples; obtain protocol-required pathology materials and reports.
Support maintenance of databases, tracking systems, and study metrics.
Serve as a primary point of contact for study participants and families, respond to inquiries, provide ongoing study-related education, and monitor participant compliance with study requirements and procedures.
Screen, pre-screen, recruit, and determine participant eligibility according to protocol requirements.
Schedule and complete protocol-required activities within protocol-defined visit windows.
Coordinate and track pharmacokinetic, pharmacodynamic, imaging, biomarker, quality-of-life, and patient-reported outcome assessments.
Support continuing, annual, and amendment reviews and study-closure submissions by maintaining regulatory binders, study files, delegation-of-authority logs, and associated documentation; obtain required signatures and approvals and track deadlines and submission requirements.
Assist with adverse-event reporting and protocol-deviation documentation.
Develop and maintain study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication.
Support protocol activation, implementation, conduct, and closeout, and coordinate protocol-specific procedures and operational requirements.
Identify and resolve protocol implementation issues in collaboration with the principal investigator 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 implementation of approved protocol amendments.
Maintain accountability records and inventories for study supplies, kits, equipment, and research materials; track inventory levels and expiration dates, order supplies and equipment as needed, and coordinate receipt and distribution of study materials.
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 AD&D insurance.
Health Savings Account and health-care and dependent-care Flexible Spending Accounts.
Transit and parking commuter benefits.
Short-term and long-term disability.
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, including critical care, hospital indemnity, accident insurance, legal assistance, and identity-theft protection.
Position may be eligible for a discretionary variable incentive bonus.