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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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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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In this collaborative role, you will be responsible for the research and development of AML procedures, regulatory engagement, and issue management related to our AML/KYC program, making a significant impact as our business continues to grow.
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Knowledge of Occupational Health, Worker’ Compensation System, OSHA, infectious diseases, wellness and regulatory compliance programs. MelroseWakefield Hospital and Lawrence Memorial Hospital are distinguished by the range of high-quality clinical care and services.
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Works collaboratively with Research Management and Compliance as necessary to ensure the appropriate fiduciary and regulatory responsibility of the research enterprise. Across Mass General and Brigham (which includes Brigham and Women’s Faulkner Hospital) sites, the integrated department will occupy approximately 185,000 square feet of office, clinical, and research space, and perform over 300,000 ambulatory and inpatient consultation visits per year.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Maintains updated Policy and Procedure Manuals using the NCCLS format in compliance with regulatory agencies ensuring documentation of Supervisor and Medical Director review annually and at revision.
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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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We’re bringing together top talent from academia, industry, and startups to build a new model for innovative R&D. As an incubator within the Schmidt Futures Network, we identify high-impact scientific or technical research and development opportunities, ultimately defining and launching these projects as Focused Research Organizations.
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Ensure robustness, reproducibility, and regulatory compliance of biomarker assays and data generated across clinical studies. Strong knowledge of biomarker technologies and methodologies, including genomics, proteomics, imaging, and flow cytometry, as applied to clinical research.
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Under the direction of the Hospital Coding Manager or Supervisor, and exercising independent judgment within the scope of the job, the Hospital Inpatient Coder II assigns applicable ICD-10 Codes, Present on Admission (POA), Hospital Acquired Condition (HAC), and Patient Safety Indicators (PSI) using current industry standards, the Official Coding Guidelines, Coding Clinic, UHDDS and regulatory requirements.
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Research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations. You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
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The individual hired for this position will receive general direction from the Senior Clinical Research Program Manager for Clinical Research and will work as part of a team of clinical research coordinators to ensure successful study start-up, enrollment, and close-out in compliance with MGH, Mass General Brigham, NIH, and FDA regulations and guidelines.
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Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trials, Data Entry, Drug Discovery, Due Diligence, Electronic Components, Gene Therapy, Lifesciences, Medical Research, Microsoft Office, Modeling And Simulation, Patient Care, Physics, Project Management, Translational Medicine.
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PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.
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The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases.
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clinical research company regulatory compliance jobs Company: Wirb Copernicus Group in Waltham, MA
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