Senior Clinical Research Associate (Oncology Experience Required) - South West England, UK - FSP

With diverse teams and continuous learning opportunities, the SCRA can explore career paths and expand skills across clinical research.

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understand 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 timelines 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 indicate 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).

Candidate Profile

You’ll thrive in this role if you bring:

• 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 organisation.

Required Qualifications

• Bachelor’s degree or in a related field.
• At least 12 months’ recent experience in oncology trials and RECIST criteria.
• Experience in identifying and building effective relationships with investigator site staff and other stakeholders.
• Fluency in English, both written and spoken.

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.