Site Monitor II / Clinical Research Associate II - Bilingual French & English - FSP

JOB SUMMARY:

The Senior CRA (sCRA) is a study-level role, working on specific, assigned protocols with assigned investigative sites. The sCRA will coordinate with the Site Care Partner to transition site management accountability at the point of the site initiation/activation. The sCRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level through study conduct and close-out. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement onsite visit requirements. The sCRA will assure that the site is compliant with the protocol and is inspection ready in collaboration with the SCP as required.  The Level 1 sCRA s should have at least three years of clinical trial experience and will need to speak the local language of the countries they will monitor in. Level 1 sCRAs will also have at least three years demonstrated experience of monitoring (virtual or onsite).

JOB RESPONSIBILITIES:

Accountable for site start-up and activation:

• Maintain a thorough knowledge of assigned protocols 

• Supports activities related to site initiation, including training, collection of necessary documentation, and access to systems 

• Ensure site monitoring readiness in anticipation of first subject first visit 

• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators. 

• Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals eg. recruitment, data entry timelines etc). 

Accountable for study conduct and close-out:

• 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 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 

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. 

• Performs 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. 

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 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. 

• Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. 

• Review 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.) 

• Conduct Follow-up for Escalated AEM Report Query 

• Check 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) 

• Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required. 

• Check 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). 

• Act as the primary liaison with site personnel. 

• May attend Investigator Meetings and/or other face to face meetings. 

• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. 

• Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. 

• Support the site with revision and submission of ICD documents (and amendments). 

• Collect and review site essential documents and ensure site regulatory file is complete and accurate. 

• Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms. 

• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback. 

• Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures. 

• Follow the Clinical Monitoring/Study Monitoring Plan (CMP/SMP) and proactively put in place mitigations for known/anticipated risks. 

• Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc. 

• Assure quality and consistency in the delivery of monitoring 

• Implement monitoring efficiencies and best practices for study/region/program 

• Support shaping the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership. 

• May act as a Subject Matter Expert on Pfizer systems and processes. 

• Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships 

• Ensures clear and open communication with relevant study team members. 

• Perform Close Out visits as assigned. 

• Develop positive Investigator relationships throughout the life of the study and escalate any concerns with Study Management. 

ORGANIZATIONAL RELATIONSHIPS:

Direct Report to DCSO (or sCRA Manager / FSP Line Manager) 

Indirect relationships with: 

• Global Study Manager/Study Operations Manager 

• Site Care Partner  

SKILLS REQUIRED:

• A minimum of 3 years of direct clinical monitoring experience in a CRO or pharma setting is required

• 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 networking and relationship building skills 

• Ability to communicate effectively and appropriately with internal & external stakeholders 

 • Ability to adapt to changing technologies and processes 

• Demonstrated experience of utilizing systems like CTMS 

• 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 

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EDUCATION:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience 

• Proficiency in French required. Working proficiency in English is required