Kristi Sullivan, Regulatory Coordinator/Office Administration

About

I am a hard-working, creative individual with over 20 years of experience. I excel in positions for office administration or clinical research. My strong sides include: organizational skills, time management, case management and regulatory.

Experience

AES/Thermo Fisher Scientific

May 2022 – Jun 2023

Remote

Regulatory Coordinator

Facilitates the study approval process and maintains regulatory compliance for all Research projects submitted to the IRB • 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 • Submits changes/corrections to the IRB as vital to maintain compliance with regulatory requirements and institutional policies. • Maintains contact with Sponsors ensuring they have all necessary documentation in a timely manner • Maintains Protocols, IB's, ICF's, 1572's, Amendments and any other documentation involving the regulatory requirements for the study/clinical trial • Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory compliance • Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor • Responds to and answers questions from the Sponsor/IRB and trial sites

AES/Thermo Fisher Scientific

Apr 2022 – May 2022

Remote

Country Approval Associate

Responsible for eISF maintenance across multiple sites which includes converting paper ISF to eISF • Revised FDA 1572 forms upon request • Main point of contact between Sponsor, IRB and site teams for Regulatory needs • Handled IRB submissions such as Continuing Reviews, terminations and site changes • Performed quality checks on all study binders across mulitple assigned sites. • Assisted sponsor contacts with gaining access to and navigating eISF

AES/Thermo Fisher Scientific

Feb 2022 – Apr 2022

Remote

Regulatory Affairs Associate

Converted CV's to the company format, updating CV's and GCP, HSR and IATA certificates as needed • Verified all licensure to be valid and correct • Maintained electronic binders in Complion system, making sure all employee CV's and credentials were up to date and uploaded into the system for trial site access • Assisted Monitors/Employees with Complion access

Self employed

Mar 2020 – Feb 2022

Remote

Freelance artist

Designed logos and custom artwork for clients, meeting criteria and deadlines • Conferred with clients, editors, authors, art directors and other interested parties regarding the nature and content of artwork to be produced

Advantage Health and Rehabilitation

Jul 2014 – Mar 2020

Mount Gilead, OH

BWC Case Manager

Managed anywhere from 150 - 200 patient cases at a time • Submitted C9 forms to the BWC for patient treatment • Entered information on calendar and kept all information current and updated daily • Reviewed incoming Physician Logs and processed accordingly • Conferred with other Physician offices, Attorneys, patients, BWC, MCO's and office staff • Followed up on all medical requests and hearings in a strict, timely manner to get treatment approved • Answered multi-line phone, relaying messages to appropriate parties • Faxing and scanning of documents • Processed payments • Helped out at front desk with the checking in/out of patients, scheduling appointments and setting them up in exam rooms

American Dental Centers

Apr 2011 – Nov 2013

Ontario, OH

Office Manager

General office Management/Receptionist duties • Patient scheduling and consultations • Filing and maintaining of patient charts • Data Entry • Insurance verification/payments • Responsible for Inventory Management and maintenance on all office equipment/machines • OSHA & HIPPA compliant • Interviewing/hiring of staff

Education

Allied Business Schools

Aug 2009 – Aug 2010

Medical Transcription certification , Medical Transcription

Bucyrus High School

Aug 1987 – Jun 1991

Diploma

Kristi Sullivan

Regulatory Coordinator/Office Administration

Skills