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As an integral member of the pharmacy team, the Clinical Trials Pharmacist is responsible for coordinating, collaborating, and providing expertise in support of drug clinical trials.
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Reviews clinical trial and non-human primate data ensuring integrity, privacy, consistency and compliance for multiple trials at a time. The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated clinical research studies across all disease groups in the Cancer Clinical Trials Office.
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Primary user of Lawson LBI, SDK, and the Boston Medical Center CTO Clinical Trials Management System (CTMS) Ensures clinical trial accounts and SDK accounts are set up appropriately and supports the study team in the financial management of clinical trials.
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Uses management skills to ensure disease groups have appropriate internal organization to effectively comply with regulatory requirements for clinical trials. Day (United States of America)The Clinical Trials Specialist II is responsible for fostering and enhancing inter-team and inter-group collaboration, serving as a source of knowledge and expertise that can be used as a resource by more junior staff.
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Significant understanding of regulatory requirements in preclinical and clinical study environment ideally for medical device studies (GCP, FDA, MDR, ICH, ISO, etc. 5+ years professional experience in conducting preclinical and clinical studies as well experience in medical device studies within industry.
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Reporting to the Senior Director, Clinical Trials Office, the Associate Director, Clinical Trials Operations is responsible for the overall management and oversight of the assigned Clinical Research Disease group managers.
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The Research Informatics Operations (RIO) Director, Account Services for Clinical Trials Research will work closely with Dana-Farber clinical research stakeholders and functional leaders within I&A to identify, prioritize, and address the clinical research data informatics needs of DFCI.
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Provides guidance to GPS ICSR processing staff on technical aspects of clinical trials and managed access programs, including configuration of the Global Safety Database and relevant reporting rules.
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Job Description - Clinical Trials Pharmacist (3279967) Dispenses research medication to subjects enrolled in clinical trials. Clinical Trials Pharmacist. Acts as a liaison for principal investigators, the research office, sponsors, pharmacy, and the Institutional Review Board (IRB.
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The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company. Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF.
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Oversees and manages domestic, regional and/or international clinical trials conducted at Labcorp Clinical research sites, external sites, and data services projects. - Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.
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Associate Director Clinical Trials. Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects.
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Attends and participates in Institutional Review Board (IRB) meetings. Acts as a liaison between CTP and compounding, as well as other areas within the department of pharmacy. The Pharmacist will review protocol documents, draft instructions, dispense investigational medication, provide supervision, perform educational activities, communicate with the sponsor and study staff, participate in patient care, maintain overall responsibility for pharmacy operations in the assigned area and perform other duties consistent with the job classification and as required.
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Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team. The Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies.
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Title: clinical trials in Newton, MA
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