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Novant Health · 7 hours ago

Clinical Research Regulatory Coordinator

Wilmington, NC

Full-time

Hybrid

Entry, Mid Level

2+ years exp

Novant Health is a healthcare organization focused on providing compassionate care. The Clinical Research Regulatory Coordinator will act as an agent of physician investigators and research staff, ensuring that clinical trials comply with FDA Regulations and Good Clinical Practice Guidelines.

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Responsibilities

Prepares IRB submissions (local and central) for all new Novant Health Clinical Research protocols

Oversees and ensures that all necessary IRB reports are submitted on a timely basis

Maintains tracking of all documents submitted to the IRB to ensure that they appear on the agenda and are acknowledged by the IRB with a letter

Sends appropriate IRB correspondence to sponsors

Assists the Research Manager in developing and maintaining databases, spreadsheets and other tools for reporting activities

Develops and maintains quality assurance programs

Trains research staff for these programs and serves as a change agent for new ideas

Assists with the Research Manager in the development of standard operating procedures

Preparation of all regulatory documents for initiation of new research studies and maintains them in a complete, comprehensive and efficient manner

Communicates the status of the submission to the Research Manager

Performs regular audits and maintenance of all Regulatory documents for trials that are open to the IRB or in the follow-up phase

Is responsible for overseeing new projects and learning opportunities for the Research Division

Evaluates completed projects in an efficient and effective manner

Responsible for preparing for monitoring visits which includes but is not limited to tracking of documents, preparing reports for monitors and noticing/correcting discrepancies

Also, responsible for meeting with Monitors during visit and resolving issues that arise from the Monitoring visits

Ensure that the Regulatory Binders are maintained and up to date throughout the course of the study

Assists in completing Close-out visits of all completed studies

Demonstrates an understanding of FDA Regulations, Good Clinical Practice Guidelines and ICH Guidelines

Implements mechanisms to ensure the regulations/guidelines are being met by the company

Acts as a liaison for Novant Health Clinical Research with the trial sponsors and maintains continuous communication and efficient coordination of all activities involved in initiating new studies and maintaining regulatory documents for all studies

Qualification

Clinical Research Regulatory ExperienceFDA Regulations knowledgeClinical Practice GuidelinesICH Guidelines knowledgeInstitutional Review Board knowledgeQuality assurance programStandard operating proceduresSelf-directedOrganizedMedical procedure skillsCustomer service experienceAdvanced computer skillsEffective communication skills