Specialist, Regulatory & Site Activation

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Skills you'll use

What you'll do

• _Tasks may include but are not limited to:_
• Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
• Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
• Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements
• Review and provide advice on country timelines for the assigned studies
• Effectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissions
• Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines and relevant study specific plans.
• Track study-specific regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the RAM
• Proactively identify risks and generate mitigation strategies at country/site level
• Advise the RAM/project team about appropriate country regulatory strategies

Who can apply

• Strong organizational and management skills
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
• Self-motivated learning about current regulatory processes and intelligence
• Excellent written and verbal communication skills to clearly and concisely present information
• Proactive by identifying potential issues in the process and anticipating solutions
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
• Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
• Team-oriented work style; seeks and gives guidance to others
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and changing environment

About Worldwide Clinical Trials

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