Ref #: 31003

Employment type: Permanent - Full-Time

Location: North, Midlands or South - England and Wales

Posted: 07-Dec-2021


Are you an experienced Independent CRA with Industry Experience looking for a permanent, regional home-based position? We are offering a number of single-sponsor aligned roles. Apply to ICON today!

Here in the ICON FSP team, we've entered into a partnership to supply additional full-time, permanent home-based Independent CRAs to be aligned with a top-10 multinational pharmaceutical and biopharmaceutical company.

Your focus will be the management of Biopharma or Oncology Clinical Trials (depending on your requirement) on a monitoring basis.

You will need to be well-versed in the role of an Independent CRA, including experience of independent monitoring visits, Site Initiation Visits and Close-Out Visits.
There are regional positions all over the UK.

What is Offered;
* Strong Salary package + car allowance and benefits
* Permanent career opportunity, including extensive training period.
* Home-based flexibility

You can also expect the following;
• Clear career progression plan – CRA I, II and III to Project Manager.
• You'll be provided with full training materials, - involving a training ramp-up period before you are assigned a clinical study.
• Operating within a close-knit, supportive team, with a mentor (operating in the same role) assigned to support.
• Dual support model (FSP Model – ICON Manager & Function Manager) and guidance and training provided by a localized team.

The Role and your Responsibilities;
• To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
• Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;

What is Required;
• Degree (BA/BS/BSc) in life sciences or qualified nurse preferable
• At least 6 months CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site
• Experience of clinical trial set up and contract negotiation preferred, but not essential
• EDC working experience
• Full-time availability

Contact to discuss in more detail.