Job DescriptionInova's Cancer Center is seeking a Full Time Clinical Research Nurse to join the team. An ideal candidate will be able to adhere to the following functions:Adheres to ICH- GCP, DHHS( OHRP and FDA), and Inova Health System guidelines when implementing research trials to ensure highest quality research within Inova Health System from site selection to study closure. Financial Management/Research Billing: Coordinates financial aspects of clinical trial implementation from protocol feasibility through to study closure. Professional Development: Makes a continuous effort to foster self-development, enhance work related skills and improve job performance and expertise. Quality Assurance/Regulatory Compliance: Utilizes and adheres to Inova standards, GCP, DHHS (OHRP and FDA) guidelines to ensure the highest quality research within Inova. Teamwork: Communicates effectively and works in collaboration with the research team in order to meet research study and departmental objectives. Demonstrates respect and understanding of other clinical disciplines and departments.Job ResponsibilitiesReview protocol to assess study requirements in determining feasibility (ie clinical, financial, logistical) for site participation and provides feedback to PI and research manager/department director.Has detailed knowledge of all components of the research study protocol and research procedures by creation of study tools (packets/checklists), training hospital staff and departments as needed in the management of the research subject.Provide teaching and act as a resource to non-licensed research personnel on the disease and/or system being evaluated or tested within the research study.Prepares complete eProtocol research applications and follows up on review and approval of same, addressing any concerns. Completes and submits all regulatory documents to IRB and study sponsor, as required, prior to any research activities being initiated until study completion.Maintains complete and organized regulatory documents, including CVs, licenses, and training certificates up-to-date throughout study duration.Manages multiple research studies as established in collaboration with the research manager/department director.Collaborates with PI and/or supervisor to determine eligibility when appropriate. Maintains study enrollment as contracted with sponsor. Ensures no protocol violations by appropriate subject eligibility and enrollment in a research study and completion of all tests/procedures within the time frame indicated in the protocol.Attends sponsor-initiated meetings, conference calls, and webinars to ensure ongoing education regarding research in general, and the protocol, in particular.Performs protocol and general research procedures as needed, (ie, providing complete organized clear/appropriate documentation for study related activities; maintaining screening/enrollment logs/tracking systems, as required by the sponsor/department; accurately storing, logging and locking study drugs/devices; maintaining up-to-date investigational drug/device accountability logs; preparing dangerous goods for shipment according to Inova/state/federal regulations).Distributes and administers investigational drug or assists other research personnel and non-research clinical staff with administration of same according to IHS nursing guidelines under the supervision of the PI.May have access to medication storage area, and maintains the regulatory compliance of this area if applicable.Provides subject information/teaching on medication uses side effects and administration as appropriate.Prepares for a regulatory monitoring visit by assuring all CRF's are completed, source documentation available and regulatory documents are complete and filed appropriately.Assists research team in their monitor visit preparation as needed.Utilizes critical thinking to collect, analyze, and evaluate all relevant information prior to taking action. Prioritizes tasks and activities appropriately.Communicates well with sponsors, study collaborators, and the IRC. Financial Management/Research Billing:Coordinates financial aspects of clinical trial implementation from protocol feasibility through to study closure.Prepares and negotiates the study budget with the sponsor by reviewing necessary documents including appropriate time, effort and resource allocation needed for the study in consultation with the PI and research manager/ Department Director.Possess a working knowledge of CPT codes, CMS guidelines, Hospital and Professional fees, etc.Submits a complete eProtocol financial submission with all required Business Office attachments (Internal and sponsor fee agreement, Coverage Analysis, QCT, checklist, etc.).Maintains a working understanding of research billing and compliance policies and processes for investigational drugs and devices to ensure appropriate billing of subject, 3rd party payers and the research fund.Assists the IRC Business Office in identifying and reconciling research costs related to tests/procedures by flagging research subjects and research visits appropriately, clearly listing research procedures/tests in the eMR as per BO guidelines and policies.Completes all Business Office procedures in a timely manner to promote prompt payment from sponsors and payment to service providers as per the CTA and IRC BO policies, such as updating the study matrix, submission of invoices, and review of patient bills when needed.Provides updates and processes any study financial amendments to the Business Office that can influence the financial aspects of the study.Communicates and collaborates with the study team and the IRC to ensure that the Clinical Trial Agreement (contract) receives the required reviews/sign- offs and are consistent with Inova's requirements prior to enrollment of subjects.Submits any CTA or financial amendments through the IRC eProtocol submission process.Professional Development: Makes a continuous effort to foster self-development, enhance work related skills and improve job performance and expertise.Maintains RN licensure and CEU requirements as per Virginia Board of Nursing.Establishes goals for self -development using available resources and knowledge of personal strengths and limitations; routinely evaluates the progression towards goals set.Acquires new and/or updated knowledge in area of expertise relevant to current position and responsibilities by participating in professional associations, attending meetings, conferences, lectures, journal clubs, or Inova ground rounds, advances in computer skills, and completes all IRC and HRPP Human Subject training per Inova and IRC policies.Completes and maintains the IRC and HRPP Human Subject Protection training as per Inova and IRC policies.Maintains own employee continuing education record.Quality Assurance/Regulatory Compliance: Utilizes and adheres to Inova standards, GCP, DHHS (OHRP and FDA) guidelines to ensure the highest quality research within Inova.Provides education and explanation to the subject/family on the purpose of the study, the informed consent document, the diagnostic procedures/treatment plan to alleviate subject/family concerns allowing the subject/family to make informed decisions.Provides informed consent to potential subjects for research studies according to institutional, state and federal regulations and policies. Assures the document is signed, dated and filed correctly.Documents the informed consent process in an enrollment note in the subject record and EPIC/eMR.Ensures patient enrollment is carried out according to protocol (ie patient eligibility is substantiated by source documentation).Completes accurate data entry into the relevant data collection form as established by protocol and project timelines after human subject visit and/or in preparation for monitor visit.Completes all data queries within the time frame required by sponsor. Ensures accuracy and completeness of information.Consistently ensures regulatory readiness for internal (RQIT) and external (FDA,sponsor) audit visits.Coordinates with the Research Quality Improvement Team to facilitate study review as needed.Notify research manager/department director, PI, IRB, sponsor and other appropriate personnel of audit visit and results as appropriate.Responds to audit reports and follows -up requests as required. Assures study and regulatory compliance by performing periodic updates to the regulatory binder and review of study documentation and appropriate reporting (ie documenting and reporting AE/SAE's and protocol violations within the IRB and sponsor's timeframe, and as required by the study; submitting amendments, continuing reviews and interim reports to the IRB and sponsor in a timely manner).Teamwork: Communicates effectively and works in collaboration with the research team in order to meet research study and departmental objectives.Demonstrates respect and understanding of other clinical disciplines and departments.Volunteers and/or displays flexibility and willingness to perform tasks outside own area of responsibility when requested as needed to meet departmental staffing needs.Displays flexibility to meet the workload priorities of the team and the department.Promptly notifies research manager/department director of variance in work schedule and complies with Inova's absenteeism policies.Attends and participates in team and study review meetings 90% of the time.Reviews team members' study tools (packets/checklists), and study summary and maintains organized study files to enable team members to cover study activities as needed.Changes focus and direction to meet the workload priorities of the team and department as needed.Participates in the orienting and training of new research staff, as appropriate.Communicates clearly to avoid misinterpretation and offers clarification or verification of information or expectation which all aids in avoiding incorrect assumptions.Maintains a productive working relationship within the team after conflict is resolved.Experience Qualifications : 3 years nursing/healthcare experience plus 1 year research training and/or protocol implementation Education BSN and/or RN in Nursing Licensure Active Virginia RN license CertificationBasic Life Support by American Heart AssociationAbout UsInova is Northern Virginia's leading nonprofit healthcare provider. Our mission is to provide world-class healthcare - every time, every touch - to each person in every community we have the privilege to serve. Inova's 18,000 team members serve more than 2 million individuals annually through an integrated network of hospitals, primary and specialty care practices, emergency and urgent care centers, outpatient services and destination institutes.Safety Always: Learn how we keep our team members and patients Safe@Inova.