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Regulatory Coordinator

Northside Hospital

This is a Full-time position in Atlanta, GA posted October 13, 2021.

Position Description The Regulatory Coordinator will be responsible for coordinating regulatory requirements integral to the conduct of clinical research.

Ensures regulatory and organizational compliance in the compilation of complete, accurate, organized critical documents for physicians, study sponsors, Contract Research Organizations, and Institutional Review Boards.

Routinely works with sensitive or confidential information, documents and issues.

PRIMARY DUTIES AND RESPONSIBILITIES
Facilitates the protocol approval process and maintains regulatory compliance for all Research projects submitted to the Central Research Office (CRO).  Prepares and maintains regulatory documents and Institutional Review Board (IRB) submissions for all Northside CRO managed protocols.

Plans, prepares and manages timelines for assigned regulatory documentation including initial submissions, meeting requests, protocol assistance and annual reports.

Initiates, collects and coordinates information to prepare regulatory documentation packages for review and Monitors and tracks status of pending protocols for Research Oversight Committee (ROC) and IRB review and approval Prepares and submits initial  protocol, informed consent form, FDA Form 1572 and the investigator brochure and any revisions throughout the course of the study  (captured above)Prepares and submits all study related recruitment materials to the sponsor & IRB for review and approval Monitors, tracks and reports  all Serious Adverse Events to IRB and Sponsor Ensures safety letters (i.e.

MedWatch reports) are reviewed by the Principal Investigator and submitted  to the IRB Prepares and submits interim status reports and final summaries to the sponsor and IRB describing study activity Oversees preparation of all closed study files for archiving in long term storage Serves as contact for research projects and maintains records and corresponds with all parties involved Develops and continuously monitors  status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory compliance Completes regulatory correspondence and composes correspondence for administrative signature as appropriate.

Coordinates and prepares mail outs including maintaining/updating distribution lists.  May be required to compile statistical reports.

Manages and maintains study postings and related updates for clinical trials webpage at Northside.com and clinicaltrials.gov.

Maintains annual update of physician and research staff curriculum vitae, professional licenses, human subjects protection training and financial disclosure forms.

Supports the IRB Manager with IRB related activities and projects.

Coordinates and participates in monitoring visits and internal /external audits of regulatory files.

Keeps abreast of federal and local regulations as it relates to clinical research and makes recommendations to modify process and procedures as necessary.

Position Requirements REQUIRED: 1.

Bachelors Degree required, preferably in a healthcare / health sciences related field.

2.

A minimum of 2 years experience in clinical research or IRB functions.

Knowledge about clinical research administration, regulatory requirements.

Knowledge of key research regulations (e.g., FDA / OHRP / ORI / DHHS / NIH).

3.

General understanding of human subject protection and Institutional Review Board regulation and operation.

4.

Computer proficient in Microsoft WORD, EXCEL, ACCESS and PowerPoint applications.

5.

Strong attention to detail and ability to adhere to policies and procedures.

6.

Effective organizational skills, effective follow-through and commitment to excellence.

7.

Strong interpersonal skills; ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.

8.

Ability to work collaboratively in a team environment.

9.

Must be flexible and adaptable as conditions and environment are unpredictable and change frequently.

10.

Able to track multiple projects simultaneously.

License/Certification Requirements: No Work Hours: 8a-4:30p Weekend Requirements: Yes On-Call Requirements: No


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