Regulatory Coordinator I (Remote) at Cedars-Sinai

Beverly Hills, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

48.11

Posted On

17 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Coordination, Clinical Trials, Protocol Submission, Compliance, FDA Regulations, IRB Documentation, Research File Maintenance, Reporting, Communication, Data Management

Industry

Hospitals and Health Care

Description

Please note for this role, you will need to confirm your eligibility to work and reside in one of the following states: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, or Georgia. The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process. 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 Research Department when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are up-to-date. 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 * Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process. * Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. * Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. * Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials. * 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.

Responsibilities

The Regulatory Coordinator prepares and submits clinical trial protocols and supporting documentation to various regulatory bodies and research committees. They also ensure ongoing compliance by managing amendments, continuations, and maintaining accurate research files.