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Job Details

Senior CRA, Croatia

Company: inVentiv Health Clinical
Location:
Reference: CRA.CROATIA
Closing Date: 24 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Join industry changing company as Senior CRA in Croatia!

Requirements:

Description

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

Position Overview

As a key member of our Clinical Monitoring team you will be responsible for all clinical monitoring activities following study guidelines, SOPs, and applicable regulations. Travel will be across the country with a maximum expectation of eight days on site per month. Supported by a local Line Manager, we can also offer you the opportunity to be sponsor dedicated and therapeutically aligned providing specialised career development.

Responsibilities

  • Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements
  • Mentor CRAs on monitoring, internal procedures, and query resolution
  • Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training
  • Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations
  • Evaluate overall performance of site and site staff
  • Ensure compliance and understanding of study requirements by site staff
  • Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff
  • Interpret data to identify protocol deviations or major risks to data integrity
  • Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines
  • Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions
  • Review and verify case report forms and other clinical data for completeness and accuracy
  • Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations
  • Generate queries and manage resolutions with site staff
  • Maintain project tracking systems as required
  • Participate in the identification and selection of investigators and clinical sites
  • Assist in the development of study specific monitoring procedures and guidelines
  • Mentor junior staff on training, guidelines, and processes
  • Complete assigned training programs and apply learning
  • Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

Benefits

  • Competitive remuneration package with excellent benefits
  • Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
  • Opportunity to work within a successful and rewarding environment

Application

If you have the required experience for this position and are eligible to work in the required location then please apply by link https://incresearch.taleo.net/careersection/ivh/jobdetail.ftl?job=17005434&tz=GMT%2B01%3A00

Apply for this job: Senior CRA, Croatia

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68
02-014 Warsaw (Warszawa)

Poland
Reasons to work for inVentiv Health Clinical
Website:  Visit Our Web Site

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