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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Description The Clinical Research Coordinator A is responsible for oversight, execution, and regulatory compliance of human subject research carried out in the Epilepsy Division of the Neurology Department.
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OR working experience with implementation of HIPAA and other healthcare-related regulatory frameworks as applied to data management; OR working experience with electronic data management systems in the field of healthcare and/or biomedical research.
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Peer-reviewed scientific publications) and regulatory purposesCompetence in budgetary control and managementProven ability of high functioning in a matrix organisationRequired/Preferred Education and LicensesA degree (BSc) and either higher degree (PhD or MSC) in Pharmacology or another appropriate scientific discipline or equivalent significant drug discovery experience (Neuroscience.
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Specific responsibilities include (but are not limited to):Supervising the clinical research nurse(s), clinical research coordinator(s), and research assistants for the team. Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
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Perform validation activities (relative to project requirements and applicable FDA regulatory guidelines)- Includes Metadata, Peer Review, UAT, etc. In this role, the Clinical Data Manager (CDM) will be responsible for performing core data management functions for Phase 1, Penn-Sponsored clinical research studies as follows:Data Quality/IntegrityPerform study level database training (End User and Sponsor Teams); Create/manage study database training curriculum; Perform re-education/training as needed.
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The Program Manager will work closely with major internal (PI, ACC CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team.
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Research, analyze and compile data for permit applications and reports to various regulatory agencies. Demonstrated ability to research and prepare concise and accurate technical documents including presentation of findings to clients, stakeholders, and/or regulatory agencies.
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Manage regulatory compliance for clinical research, including IRB submissions and progress report to trial sponsors. The Palliative and Advanced Illness Research (PAIR) Center is seeking to expand its team of experienced project managers to support a portfolio of pragmatic, randomized, multi-site clinical trials evaluating the effectiveness of palliative care interventions for seriously ill hospitalized patients.
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Clinical trial, oncology, patient recruitment, Study Oversight, Chart review, Pre-screening patients, Adverse event reporting, Oncology nursing, clinical research, regulatory, gcp, irb, edc, epic, clinical studies, recruitment.
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You will conduct discovery and translate clients’ research and business questions into actionable analyses to demonstrate data feasibility by leveraging the largest healthcare data ecosystem in the US. In collaboration with colleagues, you will identify and educate clients on the data suppliers in the HealthVerity Marketplace (HVM) that capture the necessary data elements to conduct RWD-based studies and produce regulatory-grade real world evidence (RWE.
$135,000 - $190,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Work effectively with cross-functional partners including research and development, medical affairs, regulatory affairs, manufacturing, Business Development & Licensing, market analytics, international and domestic operations, legal, scientific communications, professional education, training and development, health care compliance to successfully navigate the internal and external environments and deliver value to our customers.
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Effectively collaborate with other disciplines within the North America Legal & Compliance organization, including compliance, regulatory affairs, government affairs, and product line support services, in order to provide informed advice.
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Complete annual reports to Institutional Review Board, CTSA, FDA and other regulatory agencies. Able to perform all aspects of clinical research coordination activities and directly assigned responsibilities as it relates to operationalizing the vision of the Principal Investigator.
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Research and maintain awareness of NCQA and CMS regulatory guidance and changes, providing expert interpretation for impacts to products and customers. Facilitate customer meetings to deliver research findings or ad hoc reporting.
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research regulatory jobs in Philadelphia, PA
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