Sue Worthington

Raleigh, North Carolina, United States

ad4xws@r.postjobfree.com

linkedin.com/in/sue-worthington-32892b12

Experience

Title Clerk

Hertz

Nov 2023 - Present (3 months)

Working in the car sales division as a title clerk and handling administrative duties as well. Greet customers and help keep the store clean and organized. Responsible for ordering office supplies. Front Desk Attendant

Cozy Cat Veterinary Hospital

Mar 2023 - Oct 2023 (8 months)

Check in and check out clients. Pet and hold the friendly cats. Make and change appointments. Process prescriptions that come from outside pharmacies. Update client charts. Verify package contents and stock shelves.

Study Start Up Coordinator

PSI CRO AG

Jan 2022 - Sep 2022 (9 months)

Essential document collection and review, tracking, site communications.

-Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis.

-Customs clearance and import/export license management.

-Transition all study start-up complete sites to the Study Maintenance Associate within timeline and in general all needed preparations for site activation.

-Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.

-SSUA serves as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.

-Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety information.

-Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

-Prepares checklist for IP release according to country regulations. SSUA

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Premier Research

Jul 2019 - Dec 2021 (2 years 6 months)

-Start-Up Associate performs all country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements.

-Work with the Site Recruitment Specialist to provide study start-up metrics and site contact information.

-Essential document collection and review, tracking, site communications.

-Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis.

-Customs clearance and import/export license management.

-Transition all study start-up complete sites to the Study Maintenance Associate within timeline and in general all needed preparations for site activation.

-Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.

-SSUA serves as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.

-Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety information.

-Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

-Prepares checklist for IP release according to country regulations. Driver

Enterprise

Apr 2019 - Jul 2019 (4 months)

Drive rental vehicles from RDU Airport to and from local offices Clinical Research Associate

Duke Clinical Research Institute

Dec 2012 - Mar 2019 (6 years 4 months)

• Perform routine in-house site assessments for clinical research activities with minimal direction, for 30-50 sites.

• Use critical thinking skills to assess investigator and site qualification for a particular program.

• Work closely with study sites to complete start up by facilitating local regulatory approval and negotiating study budgets to completion.

• Track the completion of site regulatory documents in the study CTMS and ensure ongoing updates are reviewed tracked and filed appropriately.

• Review and approve site specific Informed Consent Form Templates.

• Utilize a risk based strategy to monitor sites’ compliance with study protocol/processes and regulatory guidelines.

• Collect, document, update, and report study information according to established procedures and timelines using standard templates.

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• Work with sites to ensure data collection and cleaning are complete and benchmarks/timelines for completion are maintained. Including resolving data queries and collection of source documents to support end point adjudication.

Oversee and supervise the work of a Clinical Trial Assistant/Admin Support person.

• Work closely with study sites to complete study start up by facilitating site regulatory approval and contract completion.

• Independently create new and customize existing templates to meet project needs.

• Assist Study Lead CRA and PL with cross functional project specific activities.

• Maintain site personnel accesses for the following vendors: ALMAC, Covance, RAVE, PSKW and MEdportal

• Run weekly and biweekly reports for the sponsor.

• Update CTMS database for the site management team and the monitoring team. Adding new documents, milestones, etc. Updates to DEG as well.

• Prepare and submit expense reports for leads on the trial. Clinical Trial Assistant I & II

Duke Clinical Research Institute

Oct 2005 - Nov 2008 (3 years 2 months)

Developed spreadsheets to track enrollment, screening logs, site selection and clinical supplies shipping dates.

Templates (screening log tracking, enrollment) were sent to all AROs for their use. Help members of the team and people from other trials with Excel questions and issues. Work with DCRI Shipping and CRA Lead to develop regulatory document CDs that are shipped to sites. Track inventory of CDs and reorder when necessary. Assist the CRA Lead on all other site material development, production and shipping to all ARO sites, assuring the supplies are adequate and delivered to sites in a timely manner for the Tracer trial. Follow up with sites to resolve and close action items (Follow-up items) issued by the on-site monitors. Prepare and send out weekly enrollment posters to sites for Early ACS, Improve IT and Tracer. Upload and maintain sponsor memos and safety letters to the Improve IT Inform portal for site use. Prepare and send a bimonthly report to Clinphone for the Improve It trial.; Worked on three cardiology mega trials- 8,000 to 10,000 patient trials - performing a variety of research, database, and administrative duties of a clinical and developmental nature in support of multi-center clinical trials to ensure adherence to protocol, FDA, and international guidelines, and to ensure the quality of data received during the start up and maintenance phases of trials: Developed site lists and in house site management tools, Sent interest packets and regulatory documents to potential sites. Reviewed, verified and processed all start up documents Coordinated with sponsor delegate to approve sites and request shipment of clinical drug supplies Set up and maintained site study files

Confirmed query responses in the eCRF, and closed or reissued queries as appropriate Professional Experience (cont.):

Maintained and updated site demographics on computer data base; log and file received forms. Prepare weekly and daily enrollment reports.

Staff Specialist

Duke Clinical Research Institute

Feb 2004 - Oct 2005 (1 year 9 months)

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Maintained CRA Lead's calendar, kept her apprised of her daily commitments and responded to meeting requests from other departments

Set up meetings - including finding a meeting place, procuring any needed electronics, ordering and setting up food, confirming participants' attendance, preparing needed documentation and clean up. Make travel and accommodation arrangements for the CRA lead and other team members who traveled.

Prepared expense reports and turned them into finance in a timely manner. Ordered office supplies and kept team specific supplies on hand. Responsible for getting team's time sheets signed and turned in to HR Attended all team meetings and took minutes

Processed global data requests from trial teams to update their site information Run reports to find errors in the database entries and then update (i.e. Street should be 'St.'; all states use the 2 letter abbreviation). Entered information from PI update sheets into the database. Pulled survey results for the Early trial on a weekly basis and sent to trial team Set up (associated site #, PI and facility) and maintained the ROW sites for the Early trial. Helped with the early testing process of the CTMS stages. Made suggestions of what was needed and tested functionality and user friendliness

Cashier and Pharmacy Technician

CVS Pharmacy

Nov 2001 - May 2004 (2 years 7 months)

Finance CEO's Assistant and A/P & A/R Clerk

Travel Management

Mar 1999 - Apr 2003 (4 years 2 months)

Owner's Assistant and Finance Clerk

Travel Experts, Inc.

Apr 1996 - Feb 1999 (2 years 11 months)

Shop manager

William Strickland Interiors

Apr 1993 - Jun 1994 (1 year 3 months)

Day Manager

Video Club Mall

Feb 1991 - Jul 1992 (1 year 6 months)

Co-Manager

The Wendy's Company

May 1984 - Dec 1990 (6 years 8 months)

Education

Sue Worthington - page 4

U.S. Career Institute

Medical Assistant Certificate, Medical/Clinical Assistant 2016 - 2017

Penn Foster Group

Diploma, Pharmacy Technician/Assistant

2009 - 2010

Comprehensive course designed to prepare one for state specific accreditation Penn Foster Group

Diploma, Professional Bookkeeping and Accounting Program Apr 1995 - Aug 1996

North Carolina State University

Natural Resources Recreation Major

1983 - 1986

Greenwich Central School Greenwich NYState of New York's Regent 1978 - 1983

Skills

Clinical Research Experience • Document Review • Electronic Data Capture (EDC) • Analytical Skills • Account Management • Accounting • Financial Accounting • Regulatory Guidelines • Life Sciences • Office Administration

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