Company: DOCS Global
Location: slough,United Kingdom
Reference: Ref AS-015726
Closing Date: 03 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
great permanent career opportunity for a dedicated and motivated CRA!
Roles & Responsibilities of the position
Main CRA II (Clinical Research Associate II) responsibilities:
? Administration and full investigator site responsibility for clinical studies according to Standard Operating Procedures (SOPs), ICH-GCP and local regulations;
? Ensures clinical trials are monitored such that subjects' rights, safety and wellbeing are protected and that the clinical trial data are reliable.
? Acts as a member of the project team with the goal to contribute towards efficient management of trials;
? Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
? 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;
? 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;
? Performs pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and SOPs;
? Performs initiation visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and SOPs;
? Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability;
• BSc degree in life sciences, minimum preferred qualification.
• 1-4 or more years monitoring in clinical research experience: experience in pharmaceutical or biotechnology companies but preferably in a CRO with proven track record as an accomplished CRA in UK-based IMP trials. IMP trial experience is mandatory. Medical device experience and monitoring of non-IMP trials are not acceptable without recent IMP experience.
• Therapeutic area: Oncology experience is highly recommended. Other TA experience should ideally encompass complex indications and/or rare disease and/or trials in ICU settings.
• Excellent communication and time management skills to manage multiple projects at any one time. Confident in presenting studies at site with high standards for the quality of material presented.
• Strong team member and understand the need for effective communication at all levels. You will have a demonstrable record for effective relationship building with sponsors, sites and colleagues, as well as strong management skills.
• Fluent English. Local language is mandatory for positions outside the UK.
• Excellent organisation and time management skills
• Proactivity and risk management skills
• Excellent computer skills including EDC & CTMS
• Full and clean driving licence with willingness to travel to sites 2/3 times per week
• Full and valid UK working eligibility
• Ideally able to start asap/negotiable.
* Permanent position
* Office-based and full-time
* Salary range will depend on level of skills and experience and would range from £32,000 to £33,000 per annum
*Company benefits to include 25 days annual leave plus UK bank holidays, pension, life assurance, healthcare cover, childcare Vouchers and free on site car parking)
For more information, please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
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