Clinical Research Coordinator

Guidehouse Inc.; Bethesda (MD); On-site; USD 75,000 - 110,000; Full time

Job summary

Guidehouse Inc. in Bethesda, MD is seeking a full-time on-site Clinical Trials Operations professional with oncology trials experience. You will guide junior staff, assist with onboarding, and ensure data quality across EMR/CTMS platforms while maintaining regulatory compliance.

The role supports protocol execution, documentation, and study closeout, coordinating with IRBs and sponsors to ensure inspection readiness and data integrity in a fast-paced environment.

Qualifications

• Bachelor's degree in nursing or related field.
• Minimum 2 years oncology clinical trials experience.
• Experience with EMR and CTMS systems.

Responsibilities

• Provide guidance and training to junior staff and students.
• Onboard protocol operations and study procedures.
• Enter and validate research data in approved systems.
• Coordinate specimen handling and regulatory documentation.
• Monitor participant eligibility and protocol windows.
• Support adverse event reporting and study closeout.

Skills

EMR experience

CTMS experience

Clinical research operations

Education

Bachelor's degree in Nursing/Biological Sciences/Public Health

Job description

Job Family : Clinical Trial Operations Travel Required : None Clearance Required : Ability to Obtain Public Trust

This is a full-time, on‑site opportunity in Bethesda, MD.

What You Will Do :

• 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