Senior CRA, Italy (home-based)
Company: inVentiv Health Clinical
Closing Date: 21 Dec 16
Salary (£): Competitive
One of the key success factors within any clinical drug development process is the speed and efficiency of monitoring of sites involved in clinical trials so our pharmaceutical customers can bring their drugs to market as safely and quickly as possible which ultimately changes lives. Join our well established Clinical Monitoring Team in Italy and help everyone by shortening the distance from lab to life.
Position: Senior CRA
Location: home-based, Italy
Contract: permanent, full-time
Project: allocated to one sponsor, initially for neurology (multiple sclerosis) study
- 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.
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Minimum three to five years prior clinical monitoring experience
- Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
- Strong organizational skills
- Must demonstrate good computer skills.
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Heavy travel required (up to 70% in peak time)