Senior CRA - office-based in the Amsterdam area

Salary

Core Qualifications

Key Responsibilities

• •Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• •Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• •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 via review of site source documents and medical records.
• •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.
• •May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• •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.
• •Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• •Must be able to quickly adapt to changing priorities to achieve goals / targets.
• •May act as primary liaison with project 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, and may, with supervision, lead, 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.
• •May provide training or mentorship to more junior level CRAs.
• •May perform training and sign off visits for junior CRA staff, as assigned.
• •May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.