Clinical Trial Associate (CTA) - US (CP12Ti622)

Aixial Group•Greensboro, NC

1d•Remote

About The Position

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data. We are currently looking for an enthusiastic and talented Clinical Trial Associate - this role can be home-based anywhere in the US. 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).

Requirements

Experience in clinical trials and familiar with clinical trial methodology
Experience in clinical study start‑up activities
Familiarity with regulatory processes and IRB submissions

Nice To Haves

Degree preferred
Clinical research, academic or scientific research, and/or health administration experience is preferred
Hands‑on experience with Veeva Vault, CTMS platforms, and eTMF systems preferred

Responsibilities

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.
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.
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.