Clinical Research Associate II/Senior at inVentiv Health Commercial

Job description

Job ID 15580

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 and with excellent opportunity for career development inVentiv Health really can offer you a CRA role with a difference.

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

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Prior clinical monitoring experience
• Knowledge of Good Clinical Practice/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

Compensation & Benefits

Overview 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