Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.
The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial.
Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
Primary Duties and Responsibilities
Provides supervision of other regulatory staff.
Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
May participate in internal auditing of regulatory documents.
May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.
May participate in centralized activities of the department or institution.
May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA)
and local Institutional Review Board. Primary Duties and Responsibilities
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs. ??
Qualifications
Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.
??BA/BS Degree required
Five (5) years minimum of directly related experience.
Leadership Experience: Minimum of 3 years leading a team, preferably with more than 5 staff.
Regulatory Experience: Minimum of 5 years managing 30+ studies, ideally within a Cancer Center setting.
Licenses: Specialty research certification preferred.
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#Jobs-Indeed
Req ID : 6977 Working Title : Regulatory Coordinator III, Remote Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Compliance / Quality Job Specialty : Research Compliance Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $37.66 - $64.02
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NAHQ wants to partner with you and your organization as you explore how to elevate the profession and advance the discipline of healthcare Quality & Safety.
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For customer service issues, contact us at info@nahq.org or call us at (847) 375-4720. The team is available Monday-Friday from 8 AM-4:30 PM CT.
Important Information for CPHQ Recertification
The recertification process has been streamlined. Unlike previous years, you don’t need to list out your CE activities at the time of completing your application. Instead, you will be asked to attest to having met the requirements, further aligning with the honor-based system of recertification. In the event that your application is randomly selected for audit, you may be required to list your CE activities and submit supporting documentation.
While you may participate in NAHQ learning opportunities (Learning Labs, JHQ articles, etc.), you can only claim CE credit once for each activity. Therefore, if you’ve previously earned CE from a NAHQ learning opportunity, you can’t claim it again, nor will you see the repeat CE appear in your “My Learning� tab. This includes activities used in previous recertification cycles.
Remember, if you’re recertifying during the grace period (1/1/24-1/31/24), you already had to earn your CE hours by Dec 31, 2023.
You still have time! Register today for a multi-day virtual event that addresses the most urgent and important issues facing healthcare today that offers a full schedule of educational sessions organized around NAHQ’s twice-validated healthcare quality competency framework.
We are excited to announce the release of the book “UNSTOPPABLE: Inspiring Stories of Perseverance, Triumph and Joy from Trailblazing Women in Healthcare“.
Be inspired by nine leading healthcare trailblazers, including our own CEO Stephanie Mercado, who empower us all with their vision and passions.
You’ll notice we’ve simplified the application process to recertify. You will not have to list your CE activities at the time of applying*. Simply attest that you met the requirements to complete the application.
*In the event of an audit, CPHQs may need to list activities and upload documentation in their NAHQ account.
Quality Education Resources
Join this informative session, “Quality Education Resources� Thursday, June 22 from 11-11:30 a.m. CT. You will learn about the range of NAHQ quality education resources available to you and hear directly from universities about the benefits they realized from implementing NAHQ’s content within their courses.
Maintain a Pulse on the Latest Quality & Safety Benchmarking Data
Learn more about NAHQ’s enhanced Quality and Safety Benchmarking Program, which provides timely insights to help U.S. hospitals and health systems create data-driven business cases for their quality and safety resourcing.
Understand the Variability Among Your Quality Team Through Workforce Accelerator
Join us Tuesday, May 2, at 11 a.m. CT, to learn more about the different options available to engage with NAHQ’s enterprise-wide solution, Workforce Accelerator®. Options range in size and scope and are designed to meet the various budgetary and timing needs of health systems as they embark on their quality journeys. Register today!
Healthcare Quality and Safety Workforce Report: New Imperatives for Quality and Safety Mean New Imperatives for Workforce Development
The National Association for Healthcare Quality® (NAHQ) has conducted groundbreaking research on the advancement of the quality and safety agenda and has published the results in a new workforce report. NAHQ’s Healthcare Quality and Safety Report answers the question: “Is today’s healthcare workforce doing the work that will advance critical priorities of quality, safety, equity, value, and system sustainability?� The answer is no.
Updated Maintenance Dates: Sunday, February 5, 2023
Maintenance is planned for Sunday, February 5, from 11 p.m.-4 p.m. CT. During this time, you will not have access to the “My Learning” section of your NAHQ account. We apologize for any inconvenience this may cause and thank you for your patience.
NAHQ’s Organizational Membership Subscription will serve as a one-stop shop for healthcare quality and safety training and education. Attend the February 2, at 11 a.m. CT, info session to further understand the new offering that will continue NAHQ’s focus of “Quality in Action.�
NAHQ has published an updated version of the CPHQ exam content outline.
The new exam content will take effect on March 15, 2023. Candidates planning to take the exam before March 15, 2023, can access the current CPHQ exam content outline and related resources on our website.
Missed NAHQ Next? Don’t worry, you can purchase NAHQ Next on-demand and receive access to all content for 60 days from purchase. Benefit from actionable content that addresses issues head-on and features “how-tos” and results. Buy now and have the opportunity to receive 40+ CEs.
Healthcare Quality and Safety Workforce Report: New Imperatives for Quality and Safety Mean New Imperatives for Workforce Development
Member Briefing Workshop and Healthcare Quality Week Webinar
October 7, at 12 p.m. CT
NAHQ will host an exclusive member briefing workshop where NAHQ CEO Stephanie Mercado and NAHQ President-Elect Nidia Williams will review the workforce report in-depth and prepare you to discuss it with your team and leadership during Healthcare Quality Week.
October 17, at 12 p.m. CT
To kick off Healthcare Quality Week, (HQW) NAHQ will host a complimentary webinar with NAHQ leaders to discuss the report, its impact and how you can leverage the report to your advantage.
You still have time! Register today for a multi-day virtual event that addresses the most urgent and important issues facing healthcare today that offers a full schedule of educational sessions organized around NAHQ's twice-validated healthcare quality competency framework.