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Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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There is emphasis on proactive monitoring, governance, risk identification and escalation, as well as making sound risk decisions commensurate with the business unit's risk appetite and all risk and compliance program requirements.
$20 - $25.14Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provides on-going monitoring of the participants' compliance with program's rules and regulations as approved by the State, County of San Diego, and MAAC. Attends staff meetings and trainings as assigned.
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Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s.
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Collaborates with other entities such as GRC (Governance, Risk, and Compliance), develops a hosted environment security risk management strategy consistent with changing enterprise-specific and industry-wide risk and regulatory environment.
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Advanced knowledge of pharmaceutical business, drug development, regulatory and compliance requirements with extensive knowledge of clinical operations, project management principles and tools.
$190,000 - $230,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO's; and indirectly with GMP manufacturers, QA, and Regulatory Affairs,Lead the team in monitoring and tracking global clinical supply inventories at the clinical site level for studies; maintain forecasts and provide inventory and logistics management of IP adjusting drug distribution plans with coordination of packaging, labeling at Contract Packaging Vendors.
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Follows established policies and practices to ensure compliance with Joint Commission, Title XXII and other applicable regulatory requirements. Primarily responsible for lead duties such as staff scheduling, training, supervising and monitoring for quality assurance while utilizing technical, interpersonal and critical thinking skills under the guidance and support of a supervisor.
$21.42 - $27.5 an hourFull-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
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Provides on-going monitoring of the participants' compliance with program's rules and regulations as approved by the State, County of San Diego, and MAAC. Maintain compliance with the requirements for continuing education hours and/or units (CEH or CEU) as determined by the Department of Alcohol and Drug Programs and/or other regulatory agencies.
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Builds and manages relationships with suppliers and contractors, exercise negotiation skills, and implement cost control strategies while monitoring project progress and adhering to regulatory compliance for resource management.
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BS/BA degree in life science or related field or RN and 6+ years of clinical trial experience working at a biotech/pharmaceutical company, CRO, or clinical site including a minimum of 1 year of independent monitoring experience OR.
$106,400 - $154,325 a yearFull-timeExpandUpdated 13 days ago - UpvoteDownvoteShare Job
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This position will be part of the Anti-Money Laundering (AML) Office within the Compliance. Develop insights from complex data sources that build AML transaction monitoring controls to provide support for Intuit’s money movement products.
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Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities. Ensure GCP/GVP compliance, data integrity, and take a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.
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