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4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, including development and review of imaging section of the protocol, imaging charter, site manuals, and communication plan •Deep knowledge of implementation of oncology tumor assessment performed by (1) investigator/site and (2) BICR for both solid tumors and hematological malignancy.
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Provides protocol specific training to study team, investigators, clinical research associate, and others. Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately.
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Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable. Maintain in depth knowledge of protocol, therapeutic area, and indication.
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Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training.
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Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies.
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Ensure study information and documents in Trial Master File (TMF) and applicable databases (e.g. Clinical Trials Management System) and registries (e.g. clinicaltrials.gov) are updated and maintained.
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Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Summarized Purpose: Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Fulfills and comply with all medical duties as per protocol, SOP/COP and ICH GCP and local regulations.
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Some participation in protocol writing, and initial and continuing education for Good Clinical Practice compliance. Experience in protocol assessment and implementation. Clinical research certification (such as CCRC, CCRP, CRA, IATA) preferred.
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With limited supervision and/or guidance the CRC II facilitates study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
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Communicates subject or trial procedure information to the Operations Supervisor, Charge Nurse, Investigators, Project Managers and Project Coordinators on an ongoing basis to ensure the safety and integrity of subjects and to ensure data collected for trials Ensures compliance with Good Clinical Practice (GCP), regulatory, and protocol requirements Records study data and maintains source documentation according to Good Documentation Practices.
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The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
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Clinical Research Responsibilities: Responsible for coordinating study enrollment, establishing a database of patients, protocol treatment and follow-up care for patients participating in clinical trials.
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Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems.
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Qualifications & ExperiencePhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experienceProficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
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