The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for 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 I 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).

Key Accountabilities:

Oversight of Monitoring Responsibilities and Study Conduct:

• Ensuring 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 Standard Operating Procedures (SOPs)/processes
• 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
o 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
o 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
o 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
o 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
queries
• 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)

Collaboration:

• Collaborates with primary Site Manager who will act as the primary
liaison with site personnel
• Prepares for and attends Investigator Meetings and sponsor face to face
meetings

• Participates in global clinical monitoring and project staff meetings
(inclusive of client 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

Skills:
• Networking and relationship building skills
• Ability to communicate effectively and appropriately with internal and external stakeholders
• Ability to adapt to changing technologies and processes
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Must demonstrate good computer skills and be able to embrace new technologies
• Proficiency in local language is required
• English proficiency is required
• Ability to manage required travel of up to 75% on a regular basis

Knowledge and Experience:

• A minimum of 1year experience as a clinical monitor / clinical research associate with demonstrated experience of on-site monitoring
• Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (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 Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience