Clinical Trial Associate, Clinical Operations - ...
Shionogi Inc. - Florham Park, NJ
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OverviewThe Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.ResponsibilitiesUpdate and maintain clinical systems within project timelines and review files for accuracy and completenessSupport the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)Support inspection readinessPrepare, handle and distribute Clinical Trial materials and maintenance of tracking informationAct as a central contact for the clinical team for designated project communicationsSchedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actionsAssist with preparation of meeting materials and presentationsPrepare, handle, distribute, file and archive clinical documentation and reports according to standard operating proceduresAssist with identification of potential clinical sites; maintain investigator listsSupport organization of investigator meetings/advisory boardsReview of study files periodically for accuracy and completenessTrack and manage Case Report Forms (CRFs), queries and clinical data flowUtilize JDE system to monitor funds on existing purchaseManage tracking of all clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoicesOther duties as assignedMinimum Job RequirementsBS/BA in Life Sciences preferred or demonstratable equivalent work experienceMinimum 1-year pharmaceutical industry experience in clinical development involved with Clinical TrialsMust possess basic knowledge of applicable clinical research regulatory requirements including, Good Clinical Practices (GCP)Must have basic knowledge of applicable protocol requirementsExperience with invoice review and processingPreferred Skills & ExperienceStrong written and verbal communication skillsStrong computer skills including proficiency in use of Microsoft Word and ExcelEffective time-management and organizational skillsSelf-starter, problem solver, self-motivated, actively seeks to increase responsibilityBackground should include experience with calendar management; invoice review, budget management; meeting planningAttention to detail and accuracy in workStrong customer serviceMust live a commutable distance to our US Corporate Headquarters in Florham Park, NJEssential Physical RequirementsAbility to articulate clearly and conduct verbal presentations with large and small audiences.Ability to view video display terminal imagesAbility to operate a computer keyboard and telephone.Ability to sit for extended periods of time - up to four (4) hours at a time.Ability to lift, tug, pull up to fifteen (15) pounds.You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.EEOShionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
Created: 2024-09-23