Ref #: 33370
Employment type: Permanent - Full-Time
Location: South England
Posted: 29-Oct-2021
Description
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 dominic.brady@docsglobal.com/+447584558534 to discuss in more detail.
#CRAjob
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 dominic.brady@docsglobal.com/+447584558534 to discuss in more detail.
#CRAjob