KRISTI SULLIVAN

REGULATORY AFFAIRS COORDINATOR BUCYRUS, OH, UNITED STATES 419-***-****

DETAILS

Bucyrus, OH

United States

419-***-****

adyggg@r.postjobfree.com

SKILLS

Effective Time Management

Ability to Work in a Team

Ability to Work Under Pressure

Independent and Task oriented

Fast learning ability

Coordination and organisation

PROFILE

Experience in the field of Regulatory in Clinical Research, including a position as a Country Approval Associate and a Regulatory Coordinator. Extensive background experience in Front Office positions, both medical and non-medical businesses. Dependable, responsible and reliable in fulfilling obligations. Assertive with decision making and ability to prioritize projects with an unwavering willingness to take on challenges. Projects a professional company image and maintains a pleasant, good-natured, cooperative attitude.

EMPLOYMENT HISTORY

Regulatory Coordinator at Accelerated Enrollment Solutions/ThermoFisher Scientific, Remote - Ohio

May 2022 — June 2023

• 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 Country Approval Associate at Accelerated Enrollment Solutions/ThermoFisher Scientific, Remote - Ohio

April 2022 — May 2022

• 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 Regulatory Associate Specialist at Accelerated Enrollment Solutions/ThermoFisher Scientific, Remote - Ohio

February 2022 — May 2022

• 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 Freelance Artist at Self-Employed, Bucyrus, OH

March 2020 — February 2022

• 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 BWC Case Manager/Supervisor at Advantage Health and Rehabilitation, Mt. Gilead, OH July 2014 — March 2020

• 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

Office Manager at American Dental Centers, Ontario, OH April 2011 — November 2013

• 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

Receptionist at Wise Funeral Service, Bucyrus, OH

April 1995 — April 2004

• Greeted visitors, ascertained purpose of visit and directed them to appropriate staff

• Received and recorded payments for funeral expenses, donations

• Answered phones

• Data Entry

• Operated fax machine, copy machine and laminating machine EDUCATION

Certificate in Medical Transcription, Allied Business School, Laguna Hills, CA August 2009 — August 2010

Certificate in Medical Transcription, Medical Terminology Diploma, Bucyrus High School, Bucyrus, OH

August 1987 — May 1991

General courses and College Prep English

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