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What Youll Do: Reporting to the Lead Clinical Research Associate, the CRA II/Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLights SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP.
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Position Description: As a passionate and experienced Board Certified Behavior Analyst (BCBA) looking to elevate your career to the next level, you’ll join Kaleidoscope ABA Therapy as a Clinical Manager and lead a team of dedicated BCBAs in creating a positive and transformative impact: Supervision and Leadership: Oversee and guide a team of BCBAs, providing mentorship, support, and fostering a collaborative and growth-oriented environment.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development.
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This Planner II position earns a competitive salary and great benefits, including medical, dental, vision, life insurance, disability, a health savings account (HSA), and a flexible spending account (FSA.
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Lead or Co-lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g., Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics) and external vendors to advance programs from Phase I to late-stage development.
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Coordinate the design of in vitro and in vivo studies for clinical candidates. Experience with pre-clinical in vitro and in vivo work is a plus. Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.
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The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs. Key Responsibilities In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
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Under the supervision of the Deputy Director for Zoning and in collaboration with planning team members, the Senior Planner II will conduct, manage, and lead multiple regulatory planning initiatives to create, modify, and utilize zoning to achieve the City’s and communities’ goals.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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DescriptionThis Position is located in Reading, MA.The Department of Developmental Services (DDS) seeks a caring and compassionate applicant for the role of DIRECT CARE WORKER II (DSW II) who is committed to building meaningful relationships in order to provide outstanding care and service.
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Using genome-scale CRISPR technologies, DepMap is systematically creating a catalog of essential genes across the diversity of human tumors.
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Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity. Assist with relevant administrative tasks relating to the wider operations function, such as clinical supplies, data management, TMF or patient recruitment, if assigned.
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The Clinical Laboratory Technologist will be responsible for performing high-complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.
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Title: clinical nurse ii Company: Highland General Hospital in Belmont, MA
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