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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Basic biostatistics and ability to interpret data from clinical trials and outcomes research. Our programs were developed in collaboration with Stanford Medicine and is based on 20+ years of research on over 70,000 patients across six randomized clinical trials.
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Partner with other teams involved in the end-to-end assay launch and maintenance processes, including Clinical Ops, Clinical Lab, Quality, Regulatory Affairs, Medical, Business Stakeholders, etc.
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Respond to questions from the research and development organization on an as-needed basis, including questions related to conduct of clinical trials in the United States and abroad. Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Our research aims to improve quality of life, well-being, symptom and pain management, and reduce caregiver burden:For example, a Clinical Research Coordinator to support a large multi-site clinical trial study that focuses on the comparison of care delivery models to support older adults with complex healthcare needs.
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Reporting to the VP, Clinical Research Management Dana-Farber Cancer Institute/Dana-Farber/Harvard Cancer Center, the Director will also work closely with the DF/HCC Medical Director for Clinical Trials.
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Job Description Title: Senior Research Analyst, Boston Indicators Department: Communications and Public Affairs Reports To: Executive Director, Boston Indicators FLSA Classification: Exempt FTE: 1 Supervises: None Hybrid Schedule (subject to change): Onsite Tuesday and Thursday.
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Our client, a major academic medical center in Boston and the nation's largest hospital based research program, is looking for a Clinical Research Project Manager to join a major study group dedicated to the further research and care of cardiovascular disease patients.
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Author clinical study protocol sections related to bioassays, reports and the bioassays sections of IND, IMPD, BLA/MAA, and other regulatory documents. · Partner with Clinical Science and Regulatory Science teams to provide subject matter expertise for diagnostic (and where applicable CDx development) for relevant asset(s.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Demonstrates sound clinical judgment in assessing the patient's needs for long-term care, including evaluating the home and family situation, helping the patient and family to develop an in-home care plan, exploring alternatives to in-home care and arranging for placement if necessary.
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This includes collaborating with Clinical Research, Clinical Operations, Medical Scientific Affairs, and/or vendors to develop and monitor the clinical trial safety.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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As part of the DSRE, Pathology team, you will report to the Senior Director DSRE - Pathology and serve as a project pathologist and/or project toxicology representative to project teams within the Global Pathology group in Drug Safety Research and Evaluation (DSRE) through the provision of anatomic/clinical pathology and toxicology expertise.
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clinical research regulatory affairs jobs Title: specialist in Boston, TX, Us
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