Clinical Research Coordinator IFMC Pediatric Research
Inova Fairfax Medical campus Pediatrics Research has an opening for a Full-Time Clinical Research Coordinator to join the team.
An ideal candidate will be able to adhere to the following functions:
Clinical Research Management: Adheres to GCP, FDA, and Inova Health System guidelines when implementing research studies to ensure highest quality research and human subject protection within Inova Health System from site selection to study closure. Financial Management/Research Billing: Coordinates financial aspects of study implementation and management from protocol feasibility through study close-out per Inova Research Center and Research Department policies and guidelines. Quality Assurance/Regulatory Compliance: Utilizes and adheres to Inova standards, ICH- GCP, and DHHS (OHRP and FDA) guidelines to ensure the highest quality research and Human Subject Protection within Inova. Teamwork: Communicates effectively and works in collaboration with the research team in order to meet research study and departmental objectives. Respects and understands other clinical disciplines and departments. Professional Development: Makes a continuous effort to foster self-development, enhance work-related skills and improve job performance and expertise.
- Review protocol to assess study requirements in determining feasibility (i.e. clinical, financial, and 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.
- 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. Maintains complete and organized regulatory documents, including up-to-date CVs, licenses, and training certificates 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 timeframe 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 (i.e. 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 investigational drug or assists other research personnel and non- research clinical staff with administration of same and may have access to medication storage area, according to Research Department, Pharmacy, and IHS nursing guidelines, as appropriate. Provides subject information, as appropriate.
- 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.
- 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/spoke lead. Possess a working knowledge of CPT codes, CMS guidelines, 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, i.e. 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. Attends financial meetings regularly as determined by the Research Department.
- 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.
- 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 (i.e. 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 timeframe 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 with requests as required.
- Assures study and regulatory compliance by performing periodic updates to the regulatory binder and review of study documentation and appropriate reporting (i.e. 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).
- Volunteers and/or displays flexibility and willingness to perform tasks outside own area of responsibility when requested or 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 Health System absenteeism policies.
- Attends and participates in team and study review meetings greater than or equal to 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 misunderstanding/misinterpretation and asks for clarification or verification of information and/or expectations which all aid in avoiding incorrect assumptions. Maintains a productive working relationship after conflict is resolved.
- 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 participation in professional associations and attendance at meetings and conferences/lectures, attendance at journal clubs or Inova ground rounds, advances in computer skills, and 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.
- 2 years of healthcare experience plus one year of research OR 1 year of healthcare experience with a bachelor's degree a clinical research or related field.
- Bachelor's degree; proficiency in English
- BLS Certification.
- Meet qualifications for CRC certification after 2 years of Inova research experience.