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Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs.
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Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents.
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Regularly: Lyra supports your growth with our paid ICF-certified Mental Health Coaching training and ongoing coach development opportunities, amplifying your current skill set. Graduated from a comprehensive ACTP or ACSTH coaching program accredited by the ICF or hold an ICF-credential (Level 1, Level 2, Level 3M.
$33 - $38.5 an hourPart-timeWork from homeExpandUpdated 15 days ago - UpvoteDownvoteShare Job
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Review the ICF WSI and TDF. Pharmacovigilance (GSO, CME) Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function. Review the ICF WSI and TDF.
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Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
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This position performs nonprofessional direct and indirect patient care activities including personal, physical and comfort needs of patients, under the supervision of a professional nurse.
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International Coaching Federation (ICF) coaching credential–ACC, PCC, or MCC–with experience performing executive level coaching and team coaching. Desired Education and Experience: A Bachelor's or Master's degree in Innovation & Entrepreneurship, Innovation & Technology Management, Product Management, Marketing & Advertising, Fine Art–Design Specialty, or related discipline.
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Experience with T-REX software for ICF Catalogs management. Analyze, manage, reorganize, and maintain ICF Catalogs and identify improvements. Direct Access Storage Devices (DASD), SMS constructs, ACS Routines, Hierarchical Storage Management (HSM), Reporting (SAS, MXG, REXX, CLIST.
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