Clinical Trial Associate (CTA) US (CP12Ti622)

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 talentedClinical Trial Associate -this role can be home-based anywhere in the US.

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 startup activities

Familiarity with regulatory processes and IRB submissions

Handson 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 - be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.