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A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology. The Clinical Research Associate (CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study.
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As the Vice President of Preclinical & Translational Development, you will play a pivotal role in ensuring our development candidates have an efficient and successful path to initiation of clinical trials, as well as informing decisions related to their clinical development.
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Education and/or experience Bachelor’s degree, preferably in areas such as biological sciences, health care management or life sciences research; BSN/RN or experience with management of clinical trials.
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We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia.
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Summary: We are seeking a highly motivated Clinical Research Associate (CRA) to be responsible for supporting the Clinical Development Team to ensure the execution of assigned trials according to the study timelines and company goals and in compliance with ICH GCP, country regulations, and SOPs. Your primary role involves oversight of CRO investigative site management activities from the Sponsor perspective (ie, in-house CRA responsibilities.
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In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials. This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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We are seeking a Senior Clinical Trial Specialist to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio's SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies.
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The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Support Office (CRSO) has experienced unprecedented growth in the recent years and is seeking an Assistant Clinical Research Coordinator for the Hematopoietic Malignancies Unit to assist with the daily needs of our clinical trials.
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Oversight of the creation of a compelling scientific communications and publication plan based on the clinical trials conducted within Pfizer Oncology. Pfizer’s in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations.
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Our investigators have made contributions in many areas, including health services research, disease prevention, patient engagement, chronic illness management, clinical trials, the role of genes and the environment in health, informatics, and delivery science.
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As part of a growing clinical development operations team, the Specialist will help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.
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The RAD is responsible for oversight of MSLs in support of BMS medicines and all phases of associated clinical trials. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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We are seeking a Clinical Research Coordinator for a global Clinical Research Institute that has been conducting Clinical Trials over the last 25 years. With nearly three decades of expertise, this Institute supports numerous companies and projects from clinical trials to claims support and regulatory services, both nationally and around the world.
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clinical trials jobs in San Francisco, CA
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