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Clinical research certification ( such as CCRC, CCRP or other certification approved by Director) preferred. Participate and coordinate in clinical research studies conducted by supervising physician.
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Summary:Reports to Director of Clinical Trials or Clinical Research Nurse Lead: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies.
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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate.
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Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future product development strategic plans interacting with upper management of potential partner/acquisition companies during Due Diligence and alliance negotiations.
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You will provide programming support to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Foster effective collaboration with cross-functional teams, such as IT, data management, and regulatory affairs, to ensure successful implementation of e-health trials. Collaborate in crafting clinical trial protocols, ensuring compliance with regulatory and ethical standards.
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Assist Clinical Scientist, Study Responsible Scientist (SRS), &/or Study Responsible Physician (SRP) in various clinical research assigned Immunology Development clinical trials.
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The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.
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Reports to Director of Clinical Trials or Clinical Research Nurse Lead: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies.
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Supply Chain Maestro: Dive into the intricate world of supply chain management, overseeing the lifecycle of investigational products for clinical trials. As a Clinical Trial Drug Supply Specialist, you'll be at the forefront of ensuring the smooth operation of clinical trials by managing regulatory compliance and investigational product activities.
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Strong experience in CRO and vendor management to support clinical trials. Experience in managing the execution of complex phase 1-3 clinical trials in cardiovascular / metabolic related clinical therapeutic areas is highly desirable.
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Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
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Strong knowledge of FDA regulations and GCP / ICH guidelines regarding clinical trial management. experience of biotech / pharmaceutical clinical operations experience. Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR's, regulatory documents (including IND, CTA documents and annual/periodic updates.
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In-depth knowledge of eClinical Solutions and their applications in clinical trials and research. Bachelor's degree in Business Administration, Healthcare Management, or a related field.
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clinical trials jobs in Norwalk, CT
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