Lead Regulatory Coordinator - The Angeles Clinic & Research Institute

Cedars-Sinai Medical Center•Los Angeles, CA

About The Position

Join Cedars-Sinai! Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report’s “Best Hospitals 2024-2025” rankings . Align yourself with an organization that has a reputation for excellence! Cedars Sinai was awarded the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles. We also were awarded the Advisory Board Company’s Workplace of the Year. This recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. Join us! Discover why we have been recognized nine years in a row on the “Best Hospital” Honor Roll by U.S. News & World Report. The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Join our team and contribute to groundbreaking 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.

Requirements

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.

Nice To Haves

Certification in Clinical Research (CCRP) from SOCRA or ACRP is preferred.

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.