**Position Objective:** 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.
**Duties and 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 4
+ Collaborate with data management personnel to ensure data quality and completeness 5
+ 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
+ Collect, review, validate, and enter research data into approved electronic systems
+ 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