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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Reviews and tracks required essential regulatory documentation from clinical sites prior to study start-up as well as updates during study conduct. Bachelor’s degree, preferably in areas such as biological sciences, health care management or life sciences research; BSN/RN or experience with management of clinical trials.
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Demonstrates a thorough knowledge of Good Clinical Practice "GCP, Good Pharmacovigilance Practices "GVP, Good Laboratory Practice "GLP, Good Documentation Practice "GDP and ICH E6 R2 compliance requirements.
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Experience creating and maintaining knowledge management, documentation, and training materials - Confluence, Jira. Typical duties involve supplying enhancements to Creative Studio tools, managing a high degree of change and ambiguity, communicating project changes and milestones, developing clear documentation, guiding teams to best practices, prioritizing input effectively, continuously evaluating system capabilities, training teams as appropriate, and supplying a clear, aligned way forward.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Assist with assessment documentation, quarterly progress notes as assigned by the Activity Coordinator. Flexibility in adapting to the changing needs of the residents is essential in a skilled nursing facility (SNF) of AHMC Seton Medical Center Coastside and AHMC Seton Medical Center.
Part-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Associate Director, Clinical Records & Information Management will partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF. This role is a member of the Clinical Records leadership team to ensure optimum implementation of the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program.
$191,335 - $247,610 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Required experiences: Recognized as Procurement Authority, Project Management, Conflict Resolution, Seasoned Negotiator, Supply Chain Management, Production Planning, Value Engineering, Cost Analysis, Financial Analysis, Quality Systems and Documentation, Regulatory Issues, Compliance, Contracting Experience, Commercial and Construction Law, Technical Experience.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Act as supply chain representative for review and approval of documentation including but not limited to batch records, BOM's, specifications, artwork, and change controls. Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation.
$194,000 - $237,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Provide documentation of existing environments (topologies). OSI model: all layers Layer-7 protection techniques relevant to network security Ability to use infrastructure as code tools (Terraform preferred) Ability to use programming languages (python, golang preferred) Nice to have: Experience using CI/CD to deploy infrastructure as code, along with the utilization of tools similar to Open Policy Agent to enforce policy before deployment Powered by JazzHR.
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Conduct Adult/Geriatric Assessments, medical history, diagnosis and treatment, health education, physician referrals, case management referrals, follow-up and clear documentation according to Matrix guidelines and protocols.
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Perform code abstraction and/or coding quality audits of medical records to ensure ICD-10- CM codes are accurately assigned and supported by clinical documentation to ensure adherence with CMS Risk Adjustment guidelines.
$25 - $35 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Assist with miscellaneous US RA CMC team-related administrative documentation/tracking and product maintenance activities. Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior stakeholders for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
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Additional responsibilities include supporting pre-or post-payment coding audit for benchmark and/or reimbursement recovery, and other coding-related activities such as pre-appointment chart audits for HCC or risk adjustment, appeals of denied claims, providing information or education to providers for specificity of documentation to align with the coding guidelines to comply with federal, state, and regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Follow remediation, accreditation, and institutional protocol for academic documentation. Assist with the maintenance of documentation for accrediting agencies and boards manuals. Come join our team as a VN Faculty Apprentice and let's train you to become a Vocational Nursing Instructor.
$36 - $40 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago
documentation job Company: Crowdstaffing in San Bruno, CA
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