Senior Clinical Research Associate - Start-Up - UK regionalised (any location).

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View: 108

Update day: 07-05-2024

Location: Sheffield Yorkshire and the Humber

Category: R & D IT - Software

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Here at the ICON FSP, we’ve entered into a partnership to supply an additional full-time, permanent home-based Start-Up CRAs to add to the existing experienced team. You will be working with a top-10 multinational pharmaceutical and biopharmaceutical company.

Your focus will be the management of Start-up processes on a monitoring basis.

You will need to be well-versed in the role of an Independent CRA, including experience of independent monitoring visits, SIVs and Close-Out Visits.

There are regional positions all over the UK.

What is Offered;
  • Excellent Salary package + car allowance and benefits
  • Permanent career opportunity, including extensive training period.
  • Home-based flexibility
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 12/18 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 dominic.brady@docsglobal.com/+447584558534 to discuss in more detail.

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Deadline: 21-06-2024

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