Lead Regulatory Coordinator - CA Heart Foundation

Cedars-Sinai Medical Center•Beverly Hills, CA

11d•Onsite

About The Position

Grow your career at Cedars-Sinai! The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. 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. 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.

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.

Nice To Haves

Certification in Clinical Research (CCRP) 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.
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.