Manager Clinical Research Informatics Jobs in Reston, VA

Position Overview

Clinical Research Coordinator, NCI: 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. Requires a Bachelor's degree in Nursing, Biological Sciences, Public Health, Health Sciences, Clinical Research, or a related field.

Additional Qualifications

Certifications & Licenses

• Bachelor's degree in Nursing, Biological Sciences, Public Health, Health Sciences, Clinical Research, or related field

Field of Study

• Nursing

• Biology

• Community and Public Health

Software

• Experience with electronic medical records, clinical trial management systems, and electronic data capture platforms

Skills

• 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

Deliverables

• 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 - Ad-Hoc

• Specimen Tracking Logs - Daily

• Study Supply Inventory Reports - Quarterly

• Study Closeout Documentation - Ad-Hoc

• Final Technical Summary Report - Ad-Hoc

Statement of Work Details

• Provide guidance and operational training to junior staff, trainees, students, and temporary personnel as requested by the Government - 1

• Assist with onboarding activities related to protocol operations and study procedures - 2

• Support continuity of operations and knowledge transfer efforts - 3

• Collect, review, validate, and enter research data into approved electronic systems - 4

• Collaborate with data management personnel to ensure data quality and completeness - 5

• Maintain inventories of study supplies, kits, equipment, and research materials

• 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

• Support maintenance of databases, tracking systems, and study metrics

• 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, and 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

• 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

• 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

• 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