Permanent CRA
Major CRO
Office based in Berkshire, or home based UK- anywhere
Introduction
Our client is one of the world's largest, and well respected drug development services companies with more than 11,000 employees in 60 countries. Our^client has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. With continued growth and investment this Global CRO is looking to appoint an experienced CRA to join their expanding UK team.^If you're looking for a diverse and stimulating work environment, one where your unique talents and skills can have a tremendous impact, you'll find it here, our clients diverse, collaborative and challenging environment can change the course of your career, seeking to promote a balance between your personal life and professional life you will be in an environment that will allow you to learn, grow and achieve.
Job Summary
As CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors;
Responsibilities:
• Site management and monitoring responsibility for clinical^studies according to SOPs, ICH Guidelines and GCP
• Drug accountability
• Data Resolution
• Oversee site agreement negotiation/ implementation
• Oversee site payments
• Co-ordination of Ethics Committee Submissions
• Assures the implementation^of project plans as assigned
Required education:
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
Essential Skills& Qualification
A minimum of 1 years UK experience as a CRA
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
Thorough knowledge of monitoring procedures(including pre-study, initiation, routine monitoring and closeout visits)
Excellent interpersonal skills are essential
Ability to prioritise and manage multiple tasks with conflicting deadlines
Candidates must be able to work independently as well as in a^team environment
These are nationwide monitoring roles with sites allocation across the UK
Self-motivated and proactive
Can travel throughout the UK as required
Occasional overnight stays required
Supplementary Requirements:
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employment Information:
Employer: CRO
Employment Type: Permanent
Hours: Full time and Part Time
Location: UK; Location Independent
Plan Start Date: Negotiable
Benefits: Pension, Healthcare, Car Allowance, Performance related bonus
Keywords:
MS Office, Medical Affairs, KOL, publications, IIS, Late Phase,lifecycle, Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Site Manager, Monitor, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility , Essential Documents, GCP, SOPs, Compliance, Training, Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, Site Manager, Quality Control, QC,EDC
Assigned Consultant: Gabrielle Gainsborough at CSL Recruitment on 01932 234682
Please feel free to call for a detailed Job Description or additional^information
Applications are reviewed within 24hrs, applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.