at INC Research LLC in Bangor, Maine, United States
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* 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 Pharmacoepidemiological Practices (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 with guidance 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.
* For the Clinical Monitoring/Site Management Plan (CMP/SMP):
o Assesses site processes
o Conducts Source Document Review of appropriate site source documents and medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate and complete
o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
o Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
o 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.
* For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
* May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). 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.
* For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
o Site support throughout the study lifecycle from site identification through close-out
o Knowledge of local requirements for real world late phase study designs
o Chart Abstraction activities and data collection
o Collaboration with Sponsor affiliates, medical science liaisons and local country staff
What we re looking for
* Bachelor s degree or RN in a related field or equivalent combination of education, training and experience
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Must demonstrate good computer skills and be able to embrace new technologies
* Excellent communication, presentation and interpersonal skills
* Ability to manage required travel of up to 75% on a regular basis