Experienced Clinical Research Associate Service- West Coast
Behavioral Health Market Context
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Qualifications
- •Experienced Clinical Research Associate - Full-Service
- •May perform investigational product (IP) inventory, reconciliation and reviews storage and security
- •Must be able to quickly adapt to changing priorities to achieve goals / targets
Responsibilities
- •Responsible for ensuring regulatory compliance, monitoring site activities, and supporting data integrity throughout the clinical study lifecycle
- •Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
- •Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
- •Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- •Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
- •Demonstrates diligence in protecting the confidentiality of each subject/patient
- •Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- •Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- •Assesses site processes
- •Conducts Source Document Review of appropriate site source documents and medical records
- •Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- •Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- •Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- •Verifies site compliance with electronic data capture requirements
- •Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
- •Verifies issues or risks associated with blinded or randomized information related to IP
- •Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, imported and released/returned
- •Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
- •Reconciles contents of the ISF with the Trial Master File (TMF)
- •Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- •Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
- •Supports subject/patient recruitment, retention and awareness strategies
- •Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- •For assigned activities, understands project scope, budgets, and timelines; manages site‑level activities / communication to ensure project objectives, deliverables and timelines are met
- •May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate
- •Ensures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements
- •Prepares for and attends Investigator Meetings and/or sponsor face‑to‑face meetings
- •Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
- •Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions
- •Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and…
- •27 more items(s)
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