Clinical Research Associate II/Site Monitor II - Vaccines - FSP

Parexel • United States, United States • 6h ago

The Clinical Research Associate II/Site Monitor II will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor II will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).

Ensuring regulatory, ICH-GCP and protocol compliance.

Uses judgement 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 Standard Operating Procedures (SOPs)/processes

Immediately communicates and escalates significant issues to the project team and develops action plans

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required

Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues

Per the Clinical Monitoring Plan (CMP) or 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 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

Utilizes 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 according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP

Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and 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 CMP and SMP

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 and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and 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 and updated training requirements (i.e., protocol amendment(s), etc.)

Conducts follow up for escalated adverse event monitoring (AEM) report query

Checks the site and 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, IP Accountability Log)

Knowledge and Experience :

A minimum of 3 years experience as a clinical monitor with demonstrated experience of monitoring

Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)

Experience monitoring vaccines trials

Education:

Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel

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