- Sumitomo Pharma (Sacramento, CA)
- …information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File ( TMF ) Specialist will be ... for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits...overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF… more
- ICON Clinical Research (San Diego, CA)
- …and escalate issues as soon as identified. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up and ... (SIS) and Informed Consent Forms (ICF): + Prepare, review and approve Global Master ICF templates for Sponsors. + Prepare, review and approve Country Master… more
- Parexel (Sacramento, CA)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File ( TMF ) documentation, site reports, ... with the set-up, running and close-out of sites in a clinical trial . **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical… more
- Abbott (Alameda, CA)
- …planning, designing case report forms (CRFs), and training of study sites. + Maintain and audit Trial Master File ( TMF ) and upload to eTMF to ensure ... Opportunity** The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to… more
- IQVIA (Carlsbad, CA)
- …phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) and verify that the Investigator's ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications: *… more
- IQVIA (Carlsbad, CA)
- …Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File ( TMF ) and Investigator's Site File ... Associate! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor… more
- IQVIA (San Francisco, CA)
- …start-up phase. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) and verify that the ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Education:… more
- IQVIA (San Francisco, CA)
- …of data queries. + Ensure that essential documents are collected and maintained in both the Trial Master File ( TMF ) and the Investigator Site File ... (ISF) in accordance with regulatory standards. + Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. + Work closely with cross-functional project teams to support study execution and ensure… more
- Cordis (Irvine, CA)
- …study tasks from start-up phase through study completion + Maintain internal Trial Master Files (TMFs) and prepare study TMF for audit readiness + Assist in ... that address unmet and critical medical needs. **Responsibilities** We are seeking a Clinical Trial Associate in Irvine, CA to join our clinical study team in the… more
- BeOne Medicines (San Mateo, CA)
- …Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular ... clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for...basis as per the study TMF QC plan + Provides input to Global Clinical… more
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