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Director Medical Research Phase 1 Clinic located in Overland Park KS Part-time - R1016529

Overland Park, KS

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Job DescriptionnJoin us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.DescriptionPURPOSErrIn this part-time (30 hours or less) role you will serve as a Principal investigatorrduring the clinical part of the early phase performed at the unit. Ensure thermedical safety and well-being of patients/volunteers during trials. Overseernetwork studies in terms of protocol review and support with strategy andrclient interaction.rr rrRESPONSIBILITIESrr•Ensure clinicalrstudies are performed to acceptable medical standards, on time, and meet therrequirements of the client, ICH, GCP and other guidelines and regulations as appropriate.•Provide medicalrsupervision to Nurse Practitioners, in regards to protocol related issues andrmedical oversight.•Providermedicalrsupport to project staff for protocol-related issues including protocolrclarifications, inclusion/exclusion determinations, and issues of patientrsafety and/or eligibility.•Review andrclarification of trial-related Adverse Events (AEs) and Serious Adverse Eventsr(SAEs).•Perform medicalrreview of Adverse Event coding. the protocol, Investigative Drug Brochure (IDB),rand where appropriate,Case Report Forms (CRFs).•Review ClinicalrStudy Report (CSR) and patient narratives, where applicable.•Communicaterappropriately and in a timely manner with clients on all medical and clinicalraspects of studies•Provide medicalrsupervision of all clinical procedures to ensure the physical well-being of therstudy subjects at all times.•Provide therapeuticrarea/indication training for the project clinical team, where applicable.•Liaison with therPhase 1 Global Safety review committee for first-in-human studies as per IQVIA procedures.•Attend studyrinitiation meetings, weekly team meetings, and client meetings, as needed orrrequested.•Serve asrMedical/Scientific Advisor and provide guidance to Project Managers on the medicalrand scientific aspects of assigned projects.•Provide support torthe proposal development team which may include, but is not limited to,rreviewing the protocol for feasibility, giving guidance as toranticipated enrollment, and general advice as to the various risks associatedrwith running a particular study.•Serve as a resource,rand may participate in strategic business development activities includingrpresentations to prospective clients, professionalrmeetings, and other business development activities for Medical &rScientific Services.•Screen volunteersrfor studies and consider the inclusion and exclusion criteria vs the medicalrhazards for each volunteer by reviewing the medical history andrthe laboratory results. Perform an adequate physical examination.•Inform volunteers onrthe purpose of the study and their rights according to the principles ofrICH-GCP and the Helsinki declaration. Obtain written informedrconsent according to GCP.•Maintain, inrconjunction with Phase I Quality Assurance, the necessary quality standardsrrelated to IQVIA requirements, SOP’srpolicies and guidelines.•Attend therscientific parts of meetings when clients presenting and proposing forthcomingrstudies.•Develop and maintainrprofessional relations with local Opinion Leaders and primary care physiciansrto ensure their high regard for IQVIA and the sciencerand ethical standards of the studies conducted.Allrresponsibilities are essential job functions unless noted as nonessential (N).rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrnnJob RequirementsnREQUIREDrKNOWLEDGE, SKILLS AND ABILITIESrr•In-depth knowledgerof GCP/ICH and applicable regulatory guidelines•In-depth knowledgerof drug development process•Excellentrpresentation skills•Computer skillsrincluding proficiency in use of Microsoft Word, Excel and PowerPoint•Strong written andrverbal communication skills including good command of the English language•Excellentrorganizational and problem solving skills•Effective timermanagement skills•Ability to managercompeting priorities•Ability to establishrand maintain effective working relationships with coworkers, managers andrclientsrrrrrrrrrrrrrrrrrrMINIMUMrREQUIRED EDUCATION AND EXPERIENCErr•A medical degreerfrom an accredited and internationally recognized medical school with a curriculumrrelevant to general medical education, and a medicalrlicense from the country or region in which he/she resides and works isrrequired, with 8 years experience in clinical medicinerincluding 5 years previous experience in clinical research role; or equivalent combination of education, trainingrand experiencerrrrrrrrPHYSICALrREQUIREMENTSrr•Extensive use ofrtelephone and face-to-face communication requiring accurate perception ofrspeech•Extensive use ofrkeyboard requiring repetitive motion of fingers•Regular sitting forrextended periods of time•Occasional travelrrrrrrEEO Minorities/Females/Protected Veterans/Disabled

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