Ref #: 33370

Employment type: Permanent - Full-Time

Location: South England

Posted: 29-Oct-2021


Here at DOCS Global, we've entered into a partnership to supply an additional full-time, permanent home-based Independent Biopharma CRAs to be aligned with a top-10 multinational pharmaceutical and biopharmaceutical company (dedicated to one sponsor).

Your focus will be the management of Biopharma Clinical Trials (UK North or Midlands region) 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.
Ideally, you need to be based in The Midlands/North UK, where the sites will be based.

What is Offered;
* Excellent Salary package
* Clear development/progression plan; (example CRA I -> CRA II -> SCRA -> LCRA/PM)
* Permanent career opportunity, including extensive training period - Training ramp-up period before study assigned (~2-3 weeks), with a mentor assigned to support
* 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 to discuss in more detail.