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.
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.
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai’s medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.
Req ID : 11799
Working Title : Lead Regulatory Coordinator - Medical Network
Department : CA Heart Foundation
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Compliance / Quality
Job Specialty : Research Compliance
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $83,532.80 - $129,480.00
