Clinical Research Associate Field Based South East and North West
Introduction
Our client is a Clinical Research Unit affiliated to the NHS that delivers World class clinical trials across all phases throughout the UK. The unit is part of the UKs first Academic Health Science Centres, working across both commercial and academically led studies and has a reputation spanning 12 years of delivering complex studies globally. Our client is looking to appoint an experienced CRA to work on a Type^II Diabetes Trial in patients hospitalised for an Acute Coronary Syndrome event. Working as part of a Global team this large study is set to run for approximately 2 years.
Job Summary
As the appointed CRA you will hold primary responsibility^for all clinical trial activity for assigned sites throughout study life cycle, ensuring efficient recruitment, reliable data collection and project timelines and objectives are met and all work is carried out to ICH GCP, trial specific processes andSOPs.
The Clinical Research Associate will be responsible for:
• Site management and monitoring responsibility for clinical studies according to SOPs, ICH Guidelines and GCP
• Efficiently set up and close down assigned clinical trials as allocated
• Ensure that all site staff are trained to study requirements
• Conduct Site monitoring visits
• Data Resolution
• Maintain study specific central records
• Provide study status updates to for regional teams
• Oversee and monitor studydrug distribution, receipt, storage and disposal
• Be first point of contact for investigator sites for day to day queries
• Assures the implementation of project plans as assigned
Required education:
• University Degree (life science) orcertification 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
Experience in cardiovascular disease and/ or diabetes
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
Thorough knowledge of monitoring procedures(including pre-study, initiation, routine monitoringand 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
Employment Information:
Employer: Academic Research/ NHS
Employment Type: 12 month Contract
Hours: Full time and Part Time considered
Location: UK; SouthEast/ North West
Plan Start Date: Negotiable
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, StudyManager, 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: Matthew Pike at CSL Recruitment on 01932 228928
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 thecountry 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.