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Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE
Location:
Abee
Description:
Job Description With support of Sr CRA/CRA and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all-phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, -Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated-documents. - Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve-Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiasedo Subjects' right, safety and well-being are protected Conducts site visits including but not limited to validation visits, initiation visits, monitoring-visits, close-out visits and records clear, comprehensive and accurate visit & non-visit-contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out. Communicates with Investigators and site staff on issues related to protocol conduct, -recruitment, retention, protocol deviations, regulatory documentation, site-audits/inspections and overall site performance. Identifies, backsses and resolves site performance, quality or compliance problems and-escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, -pharmacovigilance, legal and regional operations, HQ functional areas and externally with-vendors and IRB/IECs and Regulatory Authorities. Visit ListedBuy for more information.
Company:
Merck & Company
Posted:
October 7 2023 on ListedBuy
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More About this Listing: Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE
Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE is a Research Research Associate Job at Merck & Company located in United States. Find other listings like Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE by searching Oodle for Research Research Associate Jobs.
Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE is a Research Research Associate Job at Merck & Company located in United States. Find other listings like Associate Clinical Research Associate (ACRA) - West - CA (Northern) REMOTE by searching Oodle for Research Research Associate Jobs.