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 occupies a unique position in the clinical research industry, supporting 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 successfully 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.
PURPOSE AND MAIN RESPONSIBILITIES
Purpose
The Clinical Trial Associate assists the clinical project team in ensuring effective and efficient conduct of assigned Phase I – IV studies by providing project administration, project tracking, and support in accordance with ICH GCPs, applicable international, federal and state regulations and Standard Operating Procedures (SOPs).
Responsibilities
1. Study/Site Management
• Attend team meetings. Provide status updates during meeting, as required. Create meeting agendas, generate templates for meeting minutes, complete meeting minutes for own updates and distribute meeting minutes in accordance with the Trial Operational Plan and/or contractual scope.
• May assist in the creation and distribution of project notifications (e.g., email communications) 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 the status of sites, coordinating and supporting IRB submissions and coordinating essential document collection.
• Assist with creation of the index and complete compilation of Investigator Site File (ISF) and any other applicable files or manuals. Perform quality check 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 all site level and submissions are completed.
• Support the CTL in ordering, dispatching, and tracking of trial materials, including investigational product.
• Collect study specific data (i.e., protocol deviations, patient visit tracking, site visit tracking, etc.); enter data for project tracking into Clinical Trial Management System (CTMS) and the electronic Trial Master File (eTMF) and update on a regular basis.
• Serve as an in-house resource in support of routine site management and ensure CRAs/ICRPs are kept apprised of the status of their sites.
• 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.
2. File Management
• Assist in the tracking and review of essential documents required for successful implementation, monitoring, and management of clinical trials. This includes collection and review of essential documents required for sites to be activated and IP to be released.
• Collect central IRB approval documentation and assist CRAs/ICRPs and site staff in obtaining appropriate regulatory/IRB/IEC approval of study specific documents.
• Act as the main contact for sites for documentation purposes. Collect all relevant documentation from sites and ensure sites are provided with relevant documentation throughout the lifecycle of the study.
• Assist in the set up and maintenance of the Trial Master File (TMF)/eTMF according to Aixial SOPs and/or sponsor requirements. Work closely with Document Management to ensure TMF/eTMF is audit ready.
• Run eTMF reports/check TMF trackers to note documents coming due. Work with the study team to maintain eTMF metrics.
• Assist with periodic site file reviews to ensure compliance with GCPs and Aixial/sponsor SOPs.
• Archive study documentation and assist in preparation of TMF/eTMF for return to the sponsor at the end of the study.
3. Other Clinical Activities
• Participate in key company initiatives as representative for Clinical Operations.
• Ensure quality of work through communication skills and effective working relationships.
• Perform other tasks as assigned by the line manager.
Desirable Work Experience, Qualifications and Knowledge:
• Degree preferred
• Experience in clinical trials and familiar with clinical trial methodology
• Clinical research, academic or scientific research, and/or health administration experience is preferred
• Experience in clinical study start
‑
up activities is mandatory
• Familiarity with regulatory processes and IRB submissions is mandatory
• Hands
‑
on experience with Veeva Vault, CTMS platforms, and eTMF systems 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.