Hybrid Lead Regulatory Coordinator - Medical Network at Cedars-Sinai Medical Center
Cedars-Sinai Medical Center · Beverly Hills, United States Of America · Hybrid
- Professional
- Office in Beverly Hills
Are you ready to be a part of breakthrough research?
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.
Qualifications
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.