ABOUT THIS ROLE
The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.
Clinical Trial Monitoring and Study Conduct
Ensures regulatory, ICH-GCP 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 significant 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/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations
Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow-up
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines available hardware and software to support the effective conduct of the clinical study data review and capture
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
Manages reporting of identified issues and manages follow-up to resolution
Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan
Ensures all activities are managed by site personnel who are appropriately delegated and trained
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 to changing priorities to achieve goals / targets
Reviews Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.)
Conducts Follow-up for Escalated AEM Report Query
Checks the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
Checks site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log)
Collaboration
Will collaborate with primary Site Manager who will act as the primary liaison with site personnel
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.
Process, Standards, and Oversight
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Demonstrated networking and relationship building skills
Ability to communicate effectively and appropriately with internal & external stakeholders
Ability to adapt to changing technologies and processes
Effectively overcoming barriers encountered during the implementation of new processes and systems
Identifies and builds effective relationships with investigator site staff and other stakeholders
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Proficiency in local language preferred. English is required
Knowledge and Experience:
A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)
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
Demonstrated experience of utilizing systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice
Education:
Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Berlin |Germany :
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Bavaria |North Rhine Westphalia :
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Remote Australia |Republic of Western Australia :
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Sweden |Taipei :
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