Overview
The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO supports biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases. We are currently looking for an enthusiastic and talented Clinical Trial Associate — this role can be home-based anywhere in the UK or EU, where we have the ability to hire.
Responsibilities
* Study/Site Management: Attend team meetings, provide status updates, create meeting agendas, generate templates for meeting minutes, complete meeting minutes for own updates, and distribute minutes in accordance with the Trial Operational Plan and/or contractual scope.
* Assist in the creation and distribution of project notifications and newsletters, as appropriate.
* Assist the Project Leader (PL), Feasibility Lead (FL), Clinical Team Lead (CTL), and Clinical Research Associates/Independent Clinical Research Professionals (CRAs/ICRPs) to complete study start-up activities, including feasibility tasks, tracking site status, coordinating IRB submissions, and collecting essential documents.
* Assist with creation of the Investigator Site File (ISF) index and full compilation; perform quality checks of contents and send to sites.
* Assist with regulatory activities, complete central IRB submissions as required, and collaborate with sites/Regulatory Specialists/ICRPs to ensure site-level and submission completeness.
* Support the CTL in ordering, dispatching, and tracking trial materials, including investigational product.
* Collect study-specific data (e.g., protocol deviations, patient visit tracking, site visit tracking) and enter data for project tracking into the CTMS and the eTMF; update regularly.
* Serve as an in-house resource in support of routine site management and keep CRAs/ICRPs apprised of site status.
* Send correspondence to sites, sponsors, and project teams as needed.
* Support the clinical team with ongoing study activities, including providing support to site staff.
* Assist with invoicing and tracking of investigator payments, as needed.
* Assist with sample tracking and study logistics coordination, as needed.
* Complete tasks delegated by Senior Clinical Trial Associates.
File Management
* Assist in tracking and review of essential documents required for successful implementation, monitoring, and management of clinical trials, including collection and review of documents for site activation and IP release.
* Collect central IRB approval documentation and assist CRAs/ICRPs and site staff in obtaining appropriate regulatory/IRB/IEC approvals of study documents.
* Act as the main contact for sites for documentation purposes; collect relevant documentation and provide it to sites throughout the study lifecycle.
* Assist in the setup and maintenance of the Trial Master File (TMF)/eTMF according to Aixial SOPs and sponsor requirements; work with Document Management to ensure TMF/eTMF is audit-ready.
* Run eTMF reports and TMF trackers to note documents due; maintain eTMF metrics with the study team.
* Assist with periodic site file reviews to ensure GCP and Aixial/sponsor SOP compliance; archive study documentation and help prepare TMF/eTMF for sponsor return at study end.
Other Clinical Activities
* Participate in key company initiatives as a representative for Clinical Operations.
* Maintain quality of work through effective communication and collaboration.
* Perform other tasks as assigned by the line manager.
Desirable Work Experience, Qualifications and Knowledge
* Degree preferred
* Experience in clinical trials and familiarity with clinical trial methodology
* Clinical research, academic or scientific research, and/or health administration experience is preferred
* Experience in clinical study start-up activities
* Familiarity with regulatory processes and IRB submissions
* Hands-on experience with Veeva Vault, CTMS platforms, and eTMF systems is preferred
For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page — https://www.aixialgroup.com/join-us/
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
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