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