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The Lead Regulatory Coordinator prepares and submits large and/or complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role evaluates and works to improve the operational workflow by establishing priorities and delegating tasks within the unit.

Primary Duties and Responsibilities:

• Prepares and submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
• Advises and directs the regulatory documentation workflow within the unit as well as provides consultation to staff engaging in new clinical trails.
• Develops and governs the standard operation procedures in order to achieve consistent results.
• Develops and trains internal and external customers on regulatory workflows.
• Leads the implementation of new applications and/or systems within the unit.
• Responds to escalated data requests and questions.
• Leads cross functional meetings and provides updates on the status of all regulatory submissions.
• Coordinates site qualification visits with industry sponsors.
• Identifies quality and performance improvement opportunities and provides recommendations to improve operational efficiency within the unit.

Education:

• Bachelor's degree is required.

Licenses and Certifications:

• Certification in Clinical Research (CCRP) is preferred.

Experience and Skills:

• Five (5) years of regulatory support experience minimum.
• Ability to apply critical thinking to analyze and interpret information and/or data.
• Ability to demonstrates problem solving skills and recommends solutions.
• Ability to promote and foster participation/collaboration among individuals and groups.
• Ability to develop and deliver effective presentations.
• Ability to apply process improvement principles.
• Ability to provide and/or support a level of work excellence and accuracy; recognize and address flaws or errors that others may overlook.
• Ability to communicate expectations and priorities, and clarify roles and responsibilities.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulationsAbility to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).
• Ability to handle multiple demands and/or manage complex and competing priorities.
• Ability to work within tight timeframes and meet strict deadlines.
• Ability to demonstrate time management and priority setting skills.
• Shares knowledge, time and expertise to assist other members of the team.
• Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
• Collaborates to problem solve and make decisions to achieve desired outcomes.
• Establishes effective working relationships with cross-functional team(s).
• Responds timely, effectively and appropriately to deliverables.
• Identifies and responds appropriately to both internal and external customer needs utilizing available resources.
• Represents the company with external constituents.
• Acts as a team lead to include overseeing the work of others, assigning or allocating work to team, and ensuring tasks are completed according to deadlines and quality standards.
• Plans, leads, and directs work of staff to ensure goals and objectives are completed within established budget and deadlines are met.