* 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 years prior clinical monitoring experience
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Strong organizational skills
* Must demonstrate good computer skills.
* Travel for monitoring visits
* 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.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV. To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health Clinical delivers high quality drug development programs and clinical staffing solutions of all sizes around the world to achieve our vison - Shortening the distance from lab to lifeTM