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Provide referral and connection to: Legal services; Education and English language classes; Medical care and behavioral healthcare; Placement stability and safety services; Assistance with immigration proceedings; Assistance with guardianship proceedings; Family stabilization/counseling; Substance abuse treatment; Gang prevention services; Youth programming (such as youth mentoring, tutoring, afterschool and vocation programs, sports clubs, or other extracurricular clubs, etc.
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The IRC’s Home Study and Post-Release Services (HSPRS) for unaccompanied children in the U.S. is growing from six current IRC offices to more than 17 offices throughout the US. This is a national, multi-million-dollar project with ambitious delivery goals in a short time frame.
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Degrees offered include Juris Doctor (JD), Master of Laws (LLM), Master of Conflict and Dispute Resolution (CRES), and a minor in undergraduate legal studies. The Associate Director teaches classes and provides educational programs to law students on law school study skills and bar exam preparation while assisting with other Academic Excellence Program projects as necessary.
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Effectively collaborate and coordinate with external service providers and Arrowhead functional groups and departments such as Safety, Legal, Finance, Program Management, Medical Writing, Clinical Pharmacology, and Regulatory to achieve study deliverables.
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G, adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management May support a single study or multiple studies May lead a study with limited scope (e.g., Survival Follow-up) May interact with internal and external stakeholders (study sites, committees, etc.
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Responsibilities and Qualifications Position Requirements:Currently enrolled in an undergraduate or graduate level program in one of the following majors: Business Management, Economics, Finance, Healthcare Administration, Legal studies, or a related field of study.
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Play leadership role in a matrixed multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Clinical, PM, Legal, Medical, QA, Compliance, Medical Affairs, and SKBP) in the design, start-up, conduct and closure of assigned clinical studies, including co-development Alliance partners.
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Key accountabilities:As an InvestigatorAssumes accountability for all medico-legal, scientific integrity, human safety and medical governance aspects of PCRU studies. Supports the implementation and application of electronic health record system (PIMS) in the PCRU.Supports the development of Informed Consent Documents for allocated studies and assists in obtaining the consent from study participants.
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Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs.
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At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under supervision of Clinical Trials Manager which may include clinical research protocols, gathering patient data via methods specified in the study protocol, study reports.
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Builds and leads new cross-functional collaborations with teams in top countries (US, Germany, China, and Japan) to implement IS roadmap including, but not limited to, understanding the need for IS and how it can help address practical questions for healthcare practitioners (HCPs), defining processes on ensuring IS studies are consistent with legal and compliance requirements, designing fit-for-purpose IS studies, and executing IS studies effectively.
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Graduation from an accredited four-year college or university with a Bachelor's Degree in a field of study related to the enforcement of environmental and property maintenance codes such as urban planning, biological or environmental science, law enforcement, legal studies or a related field; plus two years of relative work experience in the area of.
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Proficient at review and negotiation of standard agreements such as Confidentiality, Material Transfer, Investigator Initiated Studies, Clinical Study and Services with minimal supervision.
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Provide input into development of study regulatory documents including health authority/IRB,CEC responses, DSUR, annual reports etc. Provide oversight with SMEs for design and finalization of clinical study protocols, and production of relevant clinical trial analyses including first impressionable results, interim analyses, CSR and ensure global consistency.
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The Senior Clinical Study Manager (Sr. CSM) will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements.
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