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Cook Research Incorporated Clinical Scientist - 2021-8819 in West Lafayette, Indiana

Clinical ScientistPosting Date 2 weeks ago (4/12/2021 10:52 PM)Requisition ID 2021-8819 Job Location(s) West Lafayette IN United States Travel 20-30% Position Type Full Time Company Cook Research Inc. Category ClinicalOverview The Clinical Scientist at Cook Research Incorporated is responsible for providing senior leadership and scientific expertise. In addition, the Clinical Scientist will coordinate with cross-functional teams in the development of strategy and oversight for the clinical study/program.Responsibilities Develop and maintain relationships with physician experts (such as National Principal Investigators, Steering Committee Members) to meet company objectives for the projectCoordinate the presentation of information to DSMB, in accordance with the DSMB Charter, including, but not limited to, data summaries and presentations, study notifications, patient summaries, and attendance at meetings when necessaryProvide technical and scientific support/guidance for a specific project or area of treatment/technology or diseaseWork with cross functional teams (Engineering, Regulatory, Business Units, etc.) to evaluate new clinical projects and study strategyDevelop clinical study designs and facilitate the transition of the project to clinical project management teamReview and provide input to clinical study-related documents, plans and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Clinical Study Overview Presentation, Progress Report)Provide support and review materials for Investigator Meetings and Site Initiation MeetingsLead efforts for the analysis, interpretation, presentation and reporting of clinical and imaging data to relevant stakeholders (project teams, executive management, physicians); collaborate with the CPMIn studies with an imaging component: Coordinate plan for receipt and review of imaging and coordinate efforts in the selection, training and management of core laboratory for independent review of imaging, as applicableWork with relevant stakeholders to develop and execute publication and presentation plan for the studyReview study data and milestones, and coordinate study strategy with relevant stakeholdersMaintain effective communication with cross functional teams and stakeholdersQualifications Advanced degree in Life Sciences or Engineering required, PhD or MD preferredExtensive experience in the conduct and management of clinical studiesWorking knowledge of the regulatory authorities and other regulatory requirements that may impact global clinical studiesConscientious, influential person with an outstanding work ethic and strong personal disciplineSufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic mannerAbility to present a professional and personable demeanor in all interactionsExperience in writing study protocols and other technical documentsQualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Physical Requirements:Willingness and ability to travel 25-50% of the timeOptionsApply for this job online ApplyShareShare the job posting with a friend ReferSorry the Share function is not working properly at this moment. Please refresh the page and try again later.Share on your newsfeed"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.Equal Opportunity Employerminorities/females/veterans/individuals with disabilities/sexual orientation/gender identity