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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Our ideal candidate would be an early to mid-career medical oncologist focused on thoracic malignancies with leadership skills to help drive the growth and visibility of our multidisciplinary program here at Mayo Clinic AZ. The successful candidate will be able to partner with our internationally recognized surgical, medical, and radiation teams in a multidisciplinary clinic; initiate, run and develop clinical trials; recruit future colleagues and drive innovation across the spectrum of care.
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Technical expertise in immunology, biomarker discovery and development in clinical trials, including assay development, validation, and data analysis. Execution: Work closely with cross-functional teams to design and execute biomarker-driven clinical trials.
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We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida.
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Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance.
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The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures.
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Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence.
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Provide CMC regulatory support for new and ongoing clinical trials, eg, manage/prepare IMPD, CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs.
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Responsibilities Process and perform quality control of expedited and non-expedited Serious Adverse Event (SAE), Adverse Events of Special Interest (AESIs), Pregnancy, Aggregate and Signal Detection Reports for all DAIT clinical trials for consistency, reportability, completeness and accuracy.
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The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.
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PRINCIPAL DUTIES AND RESPONSIBILITIES: Study Start-Up·Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
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Duration: 12 Months (Possibility of extension) Job Description: The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials.
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Performs gating, analyses and scientific review of high dimensional flow cytometry data collected from immuno-oncology clinical trials. Follows Navigate Flow Cytometry Subject Matter Expert (SME) guidance and training to deliver on fit-for-purpose analytical strategies that fulfill mechanistic endpoints of investigational clinical studies.
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Ability to participate in Graduate Medical Education and clinical research trials. Onsite laboratory, imaging (X-Ray, MRI, CT, Bone Density & Ultrasound), Health Psychology and Physical Therapy.
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Familiarity with gene therapy or rare disease therapeutics development process including patient selection for clinical trials. Demonstrated working knowledge of design controls, analytical, clinical, and manufacturing process validation requirements for IVDs, GCP, GLP, and GMP requirements; working knowledge of requirements for US and global regulatory submissions related to IVDs for use in clinical trials and for commercialization of companion diagnostics.
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clinical trials jobs Company: Ppd
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