Clinical Research Coordinator

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 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

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

• 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.

• Maintain complete and accurate source documentation

• 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 1

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

• Support continuity of operations and knowledge transfer efforts 3

• 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

Qualifications

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

* This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.