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 Senior Clinical Trial Associate - this role is home-based in the UK and EU where we have the legal entities to hire. 

PURPOSE AND MAIN RESPONSIBILITIES

Purpose

The Senior 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. 
•    Create and distribute project notifications (e.g., email communications) and newsletters, as appropriate.
•    Work closely with 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.
•    Create index and complete compilation of documentation for the Investigator Site File (ISF) and any other applicable files or manuals. Perform quality check of contents and send to sites.
•    Act as the Regulatory Lead for US sites. Complete central IRB submissions as required and collaborate with sites/Regulatory Specialists/ICRPs to ensure all site level and non-US submissions are completed. 
•    Support the CTL in ordering, dispatching, and tracking of trial materials, including investigational product.
•    Collect study specific data (i.e., study and site personnel, protocols, site status, 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.
•    Assist the Global Contracts Lead with negotiation of Clinical Study Agreements and Budgets. 
•    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 site payments, as needed.
•    Assist with sample tracking and study logistics coordination as needed.
•    Assist with study committees as needed.
•    May delegate tasks to Clinical Trial Associate (CTA) as needed.
•    May be assigned to complex studies or to a program of studies.

2.    File Management

•    Track and review 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 with set up and maintenance of 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. 
•    Conduct periodic site file review to ensure compliance with GCPs and Aixial/sponsor SOPs.
•    Archive study documentation and prepare TMF/eTMF for return to the sponsor at the end of the study.

3.   Other Clinical Activities

•    Contribute to SOP review and departmental process improvement efforts.
•    Serve as a mentor for Clinical Trial Associates.
•    Perform other tasks as assigned by manager.

Required skills and qualities
Essential Work Experience, Qualifications and Knowledge:

•    Experience in clinical trials and familiar with clinical trial methodology
•    Experience with essential documents and the management of a TMF and/or an ISF
•    Excellent written and verbal communication skills
•    Advanced understanding of medical and clinical trial terminology
•    Strong organizational and time management skills and customer service
•    Prior administrative experience

Desirable Work Experience, Qualifications and Knowledge:

•    Degree preferred, ideally a healthcare/science background clinical research, academic or scientific research, and/or health administration experience
•    Ability to multi-task, with strong attention to detail
•    Ability to be thorough in a fast-paced environment

Attributes:  

Planning and Organisational Skills

•    Good organizational/time management skills
•    Work calmly under pressure and meet agreed deadlines
•    Ability to work independently 
•    Demonstrated aptitude for continuous improvement
•    The ability to delegate tasks appropriately

Communication and Teamwork

•    Team player with an ability to build good relationships with sponsors, vendors, and internal partners
•    Work effectively and efficiently as part of a study team – supports goals and understands role
•    Good interpersonal and communication skills and the ability to operate effectively in a global working environment

People Leadership

•    Ability to serve as a mentor to peers

Technical skills

•    A good understanding of medical terminology, processes, clinical trial methodology and ICH/GCP
•    A good understanding of clinical study phases and drug development process
•    Proficient with core MS Office applications, including Word and Excel.  Creates and maintains documents and spreadsheets free of spelling or grammar errors
•    Understands and follows instructions quickly and efficiently
•    Maintains complete, accurate, and well-maintained study files
•    Able to change assignments and work focus quickly to accommodate project demands without adversely impacting other deliverables
•    Complete tasks on time with within budget

Languages
Fluent in spoken and written English.

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.