Clinical Research Associate II (oncology), Madrid
Company: inVentiv Health Clinical
Closing Date: 09 Dec 16
Salary (£): Negotiable
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: CRA II
Location: office-based in Madrid
Contract: permanent, full-time
- (if proven Portuguese language skills) May perform site visits in Portugal.
- Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
- 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 contacts.
- Apply judgment and knowledge to independently resolve site issues.
- Interpret data to identify protocol deviations or major risks to data integrity.
- Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff
- 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, identify and address any protocol deviations.
- Generate queries and manage resolutions with site personnel.
- Participate in the identification and selection of investigators and clinical sites.
- Maintain project tracking systems as required.
- Work with 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 years prior clinical monitoring experience
- Proven experience in oncology
- Portuguese language skills is a aplus
- Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
- 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)