Clinical Trial Associate

2 weeks ago

Horsham, United Kingdom Cmed Full time

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 - t his position may be home or office based in Horsham UK, or partially office based in Paris France.
Purpose

The CTA assists the 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**:
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.
- May assist the project team, and site staff in obtaining appropriate regulatory/IRB/IEC approval of study specific documents.
- Involved in the set up and maintenance of the Trial Master File (TMF) according to Aixial Group SOPs and/or sponsor requirements.
- Responsible for Trial Master File (TMF) completeness and ongoing quality reviews.
- Responsible for Trial Master File (TMF) review and reconciliation at end of study
- Assist with periodic site file reviews to ensure compliance with GCPs and Aixial Group/sponsor SOPs.
- Archive study documentation and assist in preparation of TMF for return to the sponsor at the end of the study.

Study/Site Management
- Attend team meetings. Create meeting agendas; generate and distribute meeting minutes in accordance with the project communication plan. Provide status updates during meeting, as required.
- Work with Project Leader (PL), Clinical Team Lead (CTL), and Clinical Research Associates/Independent Clinical Research Professionals (CRAs/ICRPs) to coordinate activities with the site in preparation for the initiation of the trials.
- Assist with creation and complete compilation of Investigator Site File (ISF), including pharmacy and/or site operation manuals, as applicable; perform quality check of contents and send to sites.
- Assist with the coordination of ordering, dispatching, and tracking of trial materials, including investigational product.
- May assist in the collection of study specific data (i.e., protocol deviations, patient visit tracking, site visit tracking, etc.), entering data for project tracking into Clinical Trial Management System (CTMS) and updating on a regular basis.
- Assist 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.

Other Clinical Activities
- Contribute to SOP review and departmental process improvement efforts.
- Perform other tasks as assigned by manager.

Required skills and qualities

Relevant experience or related education
Excellent written and verbal communication skills.
Ability to be thorough in a fast-paced environment.
Prior administrative experience
Ability to quickly adapt to new systems.
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.
Tasks completed on time and within quality parameters.
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.
Transparent approach, clear and precise and maintains positive, enthusiastic outlook.

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

Understands and follows instructions quickly and efficiently.
Maintains complete, accurate, and well-maintained study files.
Able to change assignments and wo

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