Lead Regulatory Coordinator – Medical Network

Job Description
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 policies.

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 standard operating procedures 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:

Minimum of five (5) years of regulatory support experience.

Ability to apply critical thinking to analyze and interpret information and/or data.

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.

Knowledge of process improvement principles.

Ability to maintain high work quality and accuracy; recognize and address flaws or errors that others may overlook.

Communicates expectations and priorities clearly; clarifies roles and responsibilities.

Interprets and applies knowledge of State, Federal, and Agency standards to comply with regulations.

Proficient in software applications and technological devices (computer, laptop, tablet, smartphone, etc.).

Handles multiple demands and manages complex and competing priorities.

Works within tight timeframes and meets strict deadlines.

Demonstrates time management and priority-setting skills.

Shares knowledge, time, and expertise to assist other team members.

Cultivates and maintains strong customer relationships and rapport with stakeholders and client groups.

Collaborates to problem solve and make decisions to achieve desired outcomes.

Establishes effective working relationships with cross-functional teams.

Responds timely, effectively, and appropriately to deliverables.

Identifies and responds to internal and external customer needs using available resources.

Represents the company with external constituents.

Acts as a team lead, overseeing the work of others, assigning work, and ensuring tasks are completed according to deadlines and quality standards.

Plans, leads, and directs staff work to ensure goals and objectives are completed within budget and deadlines are met.

About Us
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.

About the Team
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. By delivering coordinated, compassionate healthcare, you can join our network of clinicians and physicians to improve healthcare throughout Los Angeles and beyond.

Base Pay: $83,532.80 – $129,480.00

Apply here