Cedars-Sinai · 4 hours ago
Lead Regulatory Coordinator - CA Heart Foundation
Beverly Hills, CA
Full-time
Onsite
Senior Level, Lead/Staff
$84K/yr - $129K/yr
5+ years expCedars-Sinai is a renowned healthcare organization affiliated with the California Heart Center, which specializes in comprehensive cardiology care. The Lead Regulatory Coordinator is responsible for preparing and submitting complex protocols to regulatory bodies, improving operational workflows, and leading cross-functional meetings to ensure compliance with regulatory requirements.
CommunitiesHealth CareMedicalNon Profit
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 trials
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
Qualification
Required
Bachelor's degree is required
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 regulations
Ability 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
Preferred
Certification in Clinical Research (CCRP) is preferred
Benefits
Outstanding benefits package
Competitive salaries
Company
Cedars-Sinai
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.
10001+ employees
H1B Sponsorship
Cedars-Sinai has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (91)
2023 (81)
2022 (92)
2021 (92)
2020 (65)
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
Thomas Priselac
President/CEO
David Wrigley
Executive Vice President Finance, CFO and Treasurer
Recent News
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2025-12-17
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