Were hiring a Clinical Research Associate for our client, a large pharmaceutical company, to join their team. This is a permanent position.

• Coordinate and execute Phase I III clinical study protocols and oversee study data collection.
• Assist in the design and review of reporting forms, including Case Report Forms, and Informed Consent Forms, as well as other study-specific documentation
• Assist in the design and execution of clinical studies:
• Recruit and qualify clinical investigators
• Plan Investigators meetings
• Conduct, or participate in, on-site training of investigative site staff, as assigned
• Design monitoring tools
• Conduct Good Clinical Practices (GCP) monitoring visits at investigative sites
• Assess CROs and other clinical research subcontractors such as central laboratories
• Act as primary project contact to external third parties, as assigned
• Manage project timelines and critical path activities
• Help develop, communicate and manage Company standards and appropriate policies and procedures • Work with clinical teams to identify and resolve obstacles
• Establish and nurture positive relations with project sites and team (internal/external) personnel
• Perform other related duties as assigned or directed
• Approximately 20%-30% travel required

Requirements

• Bachelors Degree or equivalent in health sciences
• Minimum three years direct experience with Phase I III clinical trials
• Working knowledge of regulatory requirements (FDA, ICH) including Good Clinical Practice principles and requirements
• Demonstrated experience managing project teams and third party contractors
• Ability to manage multiple activities and shifting priorities associated with an early stage drug development company

• Significant previous exposure to biological/therapeutic research, particularly in rare diseases, is a plus
• Demonstrated ability to lead, follow and manage conflict in a complex team setting
• Proficient in the use of MS Word, Excel, and PowerPoint

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