Permanent CRA III X2 - Field Based or Office based in Italy
Major CRO - Excellent Salary and Benefits
Introduction
My client is a leading CRO which specialises in providing a full range of phase I to IV clinical development services across six^continents. My client is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to my^client for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials.
Job Summary
Our client has multiple CRA positions available ranging from I - III in^experience. As a CRA, you will be responsible for monitoring all types of clinical trials, adhering to ICH GCP, investigator integrity, and compliance with all study procedures (SOPS). They may also serve in a Lead CRA role.
Essential Skills & Qualification
The Clinical Research Associate III 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
Provides clinical and technical support for new recruits
Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File Plan
Data Resolution
Maintain study specific central records
Prepares for and attends Investigator meetings
Provide study status updates to for regional teams
Oversee and monitor study drug 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
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): Italian and English
Requirement for Business Travel: Yes
Flexible Working Hours: To be confirmed
Employment Information:
Employer: CRO
Employment Type: Permanent
Hours: Full time
Location: France; Location Independent, Home Based
Plan Start Date: ASAP
Employer Benefits: Company Pension, Life Insurance, Private Healthcare
Keywords:
MS Office, MS Project, INFORM, IMPACT, Lifecycle, Clinical Research, Clinical Operations, Clinical R&D, CRA,GCP, Site Manager, Monitor, EUCTD, ICH GCP, Clinical Study, Feasibility, Essential Documents, GCP, SOPs, Compliance, Training, Investigator Meeting, REC, Research Ethics, R&D, Trust, SMO, EDC, Budget, Contracts, C&O, Negotiation, Financial, Italy
Assigned Consultant: Matthew Pike at CSL Recruitment on 01932 234685
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.