CLINICAL RESEARCH COORDINATOR

RJIT Solutions; Bethesda (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

RJIT Solutions is seeking a Clinical Research Coordinator to support the NIH/NCI in Bethesda, MD. The role involves coordinating oncology trials, managing protocol activities, and maintaining regulatory documentation in a fast-paced clinical research environment.

The coordinator will screen and enroll participants, coordinate visits, collect data, and assist with audits and closeout. Strong knowledge of FDA regulations and ICH-GCP is required, with prior oncology trial experience preferred.

Qualifications

• Bachelor’s degree in a relevant field.
• Experience supporting oncology trials.
• Knowledge of FDA regulations and ICH-GCP.
• Strong organizational and communication skills.
• Experience coordinating multiple trials from startup through closeout.

Responsibilities

• Screen, pre-screen, recruit and enroll participants per protocol.
• Coordinate protocol-required visits, procedures, imaging, and labs.
• Collect, verify, and enter data; resolve sponsor and data queries; generate reports.
• Maintain regulatory documentation and study files; ensure GCP compliance.
• Assist with monitoring visits, audits, and training junior coordinators.
• Coordinate regulatory submissions, IRB documentation, and study closeout activities.

Skills

Oncology trials experience

FDA regulations knowledge

ICH-GCP

Project coordination

Strong organizational skills

Communication skills

Education

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

Tools

EMR systems

CTMS

EDC platforms

Microsoft Office

Job description

Clinical Research Coordinator

National Institutes ofHealth / National Cancer Institute (NCI)

RJIT Solutions is an information technology and bioscience companythat specializes in providing innovative solutions in biomedical research anddata science. We serve healthcare organizations by leveraging the expertise ofour team in science, software engineering, and program/project management. Ourcommitment to excellence has made us a trusted partner of top researchorganizations, including multiple institutes at the National Institutes ofHealth (NIH). At RJIT Solutions, we combine the agility of a small businesswith the comprehensive capabilities of a large organization to accelerateresearch and enhance decision-making processes in healthcare and researchsectors. As part of our unrelenting focus on quality and compliance, RJITSolutions' delivery is based on Certified Matured Processes including CMMI L3SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes.

Place of Performance: NCI, 10 Center Drive, Building 10, Room3-2571, Bethesda, MD 20892

Position Summary and Objectives: RJIT is seeking a Clinical Research Coordinator to support the National Cancer Institute (NCI) Office of the Clinical Director (OCD) at the NIH Clinical Center in Bethesda, Maryland.The OCD supports the conduct of intramural clinical research focused on cancerand related diseases and provides the infrastructure needed to run high-qualityclinical research in a safe patient care environment, including protocolreview, regulatory oversight, clinical informatics, data management, qualityassurance, and clinical operations support.The Clinical Research Coordinator provides comprehensive coordinationservices for oncology and cancer-related clinical trials conducted within theNCI Intramural Research Program. The role spans the full life of a study, fromprotocol activation through closeout: screening and enrolling participants,coordinating protocol-required visits, procedures, specimens, and imaging,collecting and validating research data, maintaining regulatory and sourcedocumentation, supporting monitoring visits and audits, and training newercoordinators in Good Clinical Practice. The ideal candidate brings hands-onexperience with oncology trials, working knowledge of FDA regulations andICH-GCP, and the organizational discipline to coordinate several studies atonce.

Technical Requirements: Clinical ResearchCoordinator

Participant screening, enrollment,and education

• Coordinate multiple clinical research studiessimultaneously.
• Screen, pre-screen, recruit, and scheduleresearch participants according to protocol requirements, and assesseligibility against the approved inclusion and exclusion criteria.
• Support informed consent activities forobservational and interventional studies as authorized by the PrincipalInvestigator (PI).
• Educate participants on protocol requirements,study procedures, investigational therapies, visit schedules, and theirresponsibilities as study participants.
• Serve as the primary point of contact for studyparticipants and their families, respond to their inquiries, and provideongoing study-related education.
• Monitor participant compliance with studyrequirements and protocol procedures, and conduct follow-up activitiesincluding survival follow-up, telephone contacts, and long-term studymonitoring.
• Collaborate with investigators and researchstaff to ensure participant safety and protocol adherence.

Coordination of protocol-requiredvisits, procedures, specimens, and imaging

• Coordinate protocol-required visits, clinicalprocedures, laboratory testing, diagnostic evaluations, imaging studies, andancillary services, and ensure each event is completed within theprotocol-defined visit window.
• Coordinate and track pharmacokinetic (PK),pharmacodynamic (PD), imaging, biomarker, quality-of-life (QoL), andpatient-reported outcome (PRO) assessments, and facilitate administration ofQoL and PRO instruments through paper, electronic, or interview-based methods.
• Work with clinical staff to ensure timelycollection of PK and PD samples, blood specimens, electrocardiograms (ECGs),vital signs, height and weight measurements, wearable device data, and otherprotocol-specific procedures within established timelines.
• Coordinate the collection, processing, tracking,storage, and shipment of research specimens to designated laboratories andrepositories, maintaining chain-of-custody documentation and specimenaccountability, and keep daily specimen tracking logs current.
• Obtain pathology materials, slides, tissueblocks, and laboratory reports required by protocols, and coordinate receiptand processing of outside pathology samples.
• Ensure required imaging studies, including CT,MRI, X-ray, PET, and other protocol-specific imaging, are obtained anddocumented, and coordinate acquisition of outside imaging studies and reports.

Research data collection, entry,and quality control

• Collect, review, validate, and enter researchdata into approved electronic systems, and collaborate with data managementpersonnel to ensure data quality and completeness.
• Verify case report forms (CRFs) against sourcedocumentation, resolve sponsor, monitor, and data management queries, andperform routine data quality control activities in compliance with datamanagement plans and quality standards.
• Generate study reports, workload reports,enrollment and accrual reports, protocol activity status reports, regulatorytracking reports, and data quality and query resolution reports on a monthlybasis, along with other data summaries as requested.
• Assist with the preparation of interim analyses,final study reports, and the final technical summary report.
• Support the maintenance of databases, trackingsystems, and study metrics.

Source documentation and medicalrecords

• Document participant encounters in theelectronic medical record (EMR) and other approved systems as required, andmaintain complete and accurate source documentation.
• Obtain medical records from outside providers,laboratories, hospitals, and referring physicians, review them forprotocol-relevant information, and abstract clinical information for researchpurposes.
• Ensure progress notes, laboratory reports,pathology reports, imaging reports, and other source documentation arecollected and maintained, review documentation for discrepancies, andcoordinate corrective actions.
• Maintain study files and records in accordancewith applicable requirements, and participate in quality improvementinitiatives related to documentation practices.

Regulatory documentation,monitoring, and audit readiness

• Assist with the preparation and submission ofregulatory documentation to Institutional Review Boards (IRBs), ProtocolSupport Offices, sponsors, and regulatory authorities, including continuingreview, annual review, protocol amendment, and study closure submissions.
• Maintain regulatory binders, study files,delegation-of-authority logs, and associated study documentation, obtainrequired signatures and approvals from study personnel, and track regulatorydeadlines and submission requirements.
• Assist with adverse event reporting and protocoldeviation documentation, and support compliance with federal regulationsgoverning human subjects research.
• Serve as the primary operational contact forassigned studies during monitoring visits, prepare source documentation andregulatory records for review, and facilitate sponsor, CRO, internal, andexternal monitoring activities.
• Respond to monitoring findings and requests forclarification, track monitoring action items and corrective actions, andsupport audit preparation and inspection readiness so that study records remaininspection-ready at all times.

Protocol activation, conduct, andcloseout support

• Support protocol activation, implementation,conduct, and closeout activities, and prepare study closeout documentation asneeded.
• Coordinate protocol-specific procedures andoperational requirements, and identify and resolve protocol implementationissues in collaboration with the PI and study team.
• Monitor study progress and participant accrual,and participate in multidisciplinary clinical rounds and study team meetings.
• Assist investigators in evaluating participantresponses to investigational therapies.
• Coordinate protocol amendments and theoperational implementation of approved protocol changes, ensuring protocolconduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatoryrequirements.

Study tools, trackers, andweb-based resources

• Assist with the development and maintenance ofstudy tools, trackers, calendars, worksheets, forms, questionnaires, andworkflow documents that facilitate protocol execution and team communication.

Study supply and materialsinventory

• Maintain inventories of study supplies, kits,equipment, and research materials, order supplies and equipment as needed, andtrack inventory levels and expiration dates.
• Coordinate receipt and distribution of studymaterials, maintain accountability records for study resources, and producequarterly study supply inventory reports.

Training and mentoring in GoodClinical Practice

• Provide guidance and operational training tojunior staff, trainees, students, and temporary personnel as requested by theGovernment.
• Assist with onboarding activities related toprotocol operations and study procedures.
• Support continuity of operations and knowledgetransfer efforts across the study team.

Specific Qualifications

• A Bachelor's degree in Nursing, BiologicalSciences, Public Health, Health Sciences, Clinical Research, or a related fieldis required.
• Demonstrated experience supporting clinicaltrials from startup through closeout, with experience supporting oncologyclinical trials and clinical research operations.

Required Software and Tools

• Electronic medical record (EMR) systems.
• Clinical trial management systems (CTMS).
• Electronic data capture (EDC) platforms.
• Microsoft Office Suite (Word, Excel, Outlook,and PowerPoint) for study trackers, reports, and correspondence.

Required Skills and Expertise

• Experience supporting oncology clinical trialsand clinical research operations.
• Knowledge of FDA regulations, ICH-GCP, humansubjects protections, and clinical trial methodology.
• Strong organizational, communication, andproject coordination skills.
• Demonstrated experience supporting clinicaltrials from startup through closeout.

Other Requirements

• Telework may be authorized if approved by theTask Leader, COR, and the Contracting Officer.
• This position has clinical responsibilities thatinvolve direct patient care.
• This is a full-time position (30 to 40 hours perweek), Monday through Friday, with no nights, holidays, or rotational shifts.