Clinical Research Coordinator

2 weeks ago

Lafayette, United States Medix Full time

Description:The clinical research Coordaintor manages the screening, enrollment, and maintenance of patients on clinical trials. Duties include assuring protocol compliance for all patients on trial, participation in consent process, ongoing assessments for changes in condition and adverse events, accurate and timely documentation/data entry, responsible for education and training of other staff and patients, understands the strategic and operational objectives of the research program, may performs high level financial work including budget oversight. Trains and promotes professional development of staff. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.Responsibilities:Screens potential patients for protocol eligibilityPresents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trialsPresents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trialsResponsible for review of consents to ensure proper execution of the informed consent process for study subjectsCoordinates patient care in compliance with protocol requirementsDisburses investigational drug and provide patient teaching regarding administration and other patient educational needsMaintains investigational drug accountabilityOversees the preparation of orders by physicians to assure that protocol compliance is maintainedWorking independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care teamCommunicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessmentsResponsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnelResponsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physiciansMay be responsible for the development of practice research budgetsMaintains regulatory documents in accordance with USOR SOP and applicable regulationsParticipate in scheduling monitoring and auditing visitsInteracts with the monitors/auditors while on-siteProvide input in determining, and implementing improvements to policies/processesWorks with clinic staff to solve complex issues around patient trial participationDevelops SOPs in collaboration with research and clinical teamsDue to expertise in subject matter, functions in a lead role as a resource for research staffConduct protocol-specific training for study personnel to include training of staff in preparation for study activities Review protocols and provide input on study activities in relation to areas of responsibilityMay work with SRL to determine study recruitment and enrollment goalsOversees subject recruitment and study enrollment to meet goalsLeads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials Assists SRL in feasibility assessments and study selection

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