Clinical Research Coordinator (52088)

GAP SOLUTIONS INC•Bethesda, MD

24d•$90,000 - $140,000•Onsite

About The Position

Provide services as a Clinical Research Coordinator in support of the overall functions of National Cancer Institute within the National Institutes of Health (NIH). The National Cancer Institute (NCI), Office of the Clinical Director (OCD), supports the conduct of intramural clinical research focused on cancer and related diseases. The OCD provides the infrastructure required to conduct high-quality clinical research in a safe patient care environment, including protocol review, regulatory oversight, clinical informatics, data management, quality assurance, and clinical operations support. The Government requires contractor support to provide comprehensive clinical research coordination services for oncology and cancer-related clinical trials conducted within the NCI Intramural Research Program.

Requirements

Bachelor’s degree in Nursing, Biological Sciences, Public Health, Health Sciences, Clinical Research, or related field
Experience with electronic medical records, clinical trial management systems, and electronic data capture platforms
Experience supporting oncology clinical trials and clinical research operations
Knowledge of FDA regulations, ICH-GCP, human subjects protections, and clinical trial methodology
Strong organizational, communication, and project coordination skills
Demonstrated experience supporting clinical trials from startup through closeout

Nice To Haves

Ability to communicate effectively, orally and in writing, with non-technical and technical staff
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

Responsibilities

Maintain inventories of study supplies, kits, equipment, and research materials
Collects research data and prepares information for inputs and analysis.
Collect, review, validate, and enter research data into approved electronic systems
Collaborate with data management personnel to ensure data quality and completeness
Verify case report forms (CRFs) and source documentation
Resolve sponsor, monitor, and data management queries
Perform routine data quality control activities
Generate study reports, workload reports, enrollment reports, and data summaries
Assist with preparation of interim analyses and final study reports
Ensure compliance with data management plans and quality standards
Coordinate multiple clinical research studies simultaneously
Screen, recruit, pre-screen, and schedule research participants according to protocol requirements
Assess participant eligibility in accordance with approved inclusion and exclusion criteria
Support informed consent activities for observational and interventional studies as authorized by the Principal Investigator (PI)
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
Respond to participant inquiries and provide ongoing study-related education
Coordinate protocol-required visits, procedures, laboratory testing, diagnostic evaluations, imaging studies, and ancillary services
Ensure protocol-required events are completed within protocol-defined visit windows
Coordinate and track pharmacokinetic (PK), pharmacodynamic (PD), imaging, biomarker, quality-of-life (QoL), and patient-reported outcome (PRO) assessments
Monitor participant compliance with study requirements and protocol procedures
Conduct participant follow-up activities, including survival follow-up, telephone contacts, and long-term study monitoring
Collaborate with investigators and research staff to ensure participant safety and protocol adherence
Document participant encounters in the electronic medical record (EMR) and other approved systems as required
Maintain complete and accurate source documentation
Obtain medical records from outside providers, laboratories, hospitals, and referring physicians
Review medical records for protocol-relevant information
Abstract clinical information from medical records for research purposes
Review documentation for discrepancies and coordinate corrective actions
Ensure collection and maintenance of progress notes, laboratory reports, pathology reports, imaging reports, and other source documentation
Participate in quality improvement initiatives related to documentation practices
Maintain study files and records in accordance with applicable requirements
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
Coordinate receipt and processing of outside pathology samples
Ensure required imaging studies, including CT scans, MRI scans, X-rays, PET scans, and other protocol-specific imaging, are obtained and documented
Coordinate acquisition of outside imaging studies and reports
Coordinate protocol-required clinical procedures
Collaborate with clinical staff to ensure timely collection of: Pharmacokinetic samples, Pharmacodynamic samples, Blood specimens, Electrocardiograms (ECGs), Vital signs, Height and weight measurements, Wearable device data, Other protocol-specific procedures
Ensure completion of protocol-required assessments within established timelines
Facilitate administration of Quality-of-Life (QoL) and Patient Reported Outcome (PRO) instruments through paper, electronic, or interview-based methods
Monitors subject's progress and reports adverse events.
Assist with preparation and submission of regulatory documentation to Institutional Review Boards (IRBs), Protocol Support Offices, sponsors, and regulatory authorities
Support continuing review, annual review, protocol amendment, and study closure submissions
Maintain regulatory binders and study files
Maintain delegation-of-authority logs and associated study documentation
Obtain required signatures and approvals from study personnel
Track regulatory deadlines and submission requirements
Assist with adverse event reporting and protocol deviation documentation
Ensure study records remain inspection-ready and audit-ready
Support compliance with federal regulations governing human subjects research
Serve as a primary operational contact for assigned studies during monitoring visits
Prepare source documentation and regulatory records for monitoring visits
Facilitate sponsor, CRO, internal, and external monitoring activities
Respond to monitoring findings and requests for clarification
Track monitoring action items and corrective actions
Support audit preparation and inspection readiness activities
Supports assembly, development and review of new research projects.
Assist with preparation and submission of regulatory documentation to Institutional Review Boards (IRBs), Protocol Support Offices, sponsors, and regulatory authorities
Supports the creation and management of clinical websites and web-based tools.
Assist with development and maintenance of study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication
Organizes and performs clinical research, utilizing internet and other available clinical resources.
Document participant encounters in the electronic medical record (EMR) and other approved systems as required
Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
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
Ensure protocol conduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatory requirements
Order study-related supplies and equipment as needed
Track inventory levels and expiration dates
Coordinate receipt and distribution of study materials
Maintain accountability records for study resources
Supports clinical staff develop, implement and maintain clinical research data files and materials.
Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.
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
Enrollment and Accrual Reports – Monthly
Protocol Activity Status Reports – Monthly
Regulatory Tracking Reports Monthly
Data Quality and Query Resolution Reports Monthly
Monitoring Visit Support Documentation
Specimen Tracking Logs
Study Supply Inventory Reports Quarterly
Study Closeout Documentation
Final Technical Summary Report