SUMMARY

Committed, detailed-orientated, and self-motivated professional with more than 20 years of professional experience between regulatory, compliance, scheduling, and administrative duties.

SKILLS

Regulatory/Compliance

• Protocol and Consent Development and Implementation

• Regulatory and Compliance Requirements

• Methods Planning

• Manage Regulatory Activities for IRB

• International Conference on Harmonization Guidelines (ICH), Good Clinical Practice (GCP), Health Insurance Portability & Accountability Act (HIPAA), Genetic Information Nondiscriminatory Act (GINA), US Food and Drug Administration (FDA), Institutional Review Board (IRB)

Data Management

• Participant and Study Data Management

• REDCap Database Updates

• Analytical Test Orders

Enter laboratory results from paper forms

Attention to Detail

Administrative

• Travel Arrangements

• Front Desk

• Scheduling

• Project Management

• Title clerk for cars

• Title clerk for marine and offroad equipment

Transportation

• 26’ box truck

• Deliver and pick up mail as a contract carrier for the US Post Office

EXPERIENCE

Administrative and Credentialing Specialist

April 2022-Current

Express Employment/Roshal Imaging

Organize HR Credentialing files

Complete credentialing process for new hires

Organize credentialing files for current employess

Order Employment and Education Backgrounds

Order Drug and Alcohol testing along with ordering needed immunizations

Review current documents and immunization records for completion

Laboratory Administrative Assistant

February 2022 - April 2022

Spectracell Laboratories, Inc.

Greet clients

Data entry from paper handwritten laboratory results, paying great attention to detail, as incorrect data could skew the final results

Run laboratory reports for management

Business Assistant

July 2020 – March 2022

Tracker Boat Center Bass Pro Shops

Prepare documents for closing and delivery of marine units

File documents with state and county offices for taxes and registration

Answer customer questions

Schedule delivery of marine units

Mail registrations and titles to customers

Driver (Seasonal)

Nov 2020 – August 2021;

Nov 2021 – February 1, 2022

Postal Fleet Services/Vilano Management

Contract carrier driver

Mail delivery and pickup for USPS in the Greater Houston area

Office duties as needed

Administrative Assistant

February 2020-August 2020

Ultimate Motorsports, Inc.

Prepare documents for closing and delivery of automotives

File documents with state and county offices for taxes and registration

Mail registrations and titles to customers

Answer phone

Regulatory Specialist

June 2009-Dec 2019

Avera McKennan

Manage regulatory activities for industry sponsored and investigator initiated research trials

Manage IRB correspondence

Maintain Twin Register Database

Correspond with Twin Register participants

Create and maintain questionnaire databases (Excel, SPSS)

Coordinate travel arrangements

Create accounts and order requested tests

Submit patient reports to physician office

Work closely with team lead on our new product for Pharmacogenomics (PGx).

Ordering PGx tests, maintain database, requesting medical records, and when the PGx reports are completed I then send the reports.

Send paper medical records to the hospital Health Information Management (HIM) department

Front desk back up

Develop and train staff members

Aid in writing methods, grants, Standard Operating Procedures (SOPs), and applications for industry sponsored trials

Follow, write, and maintain compliance and regulatory documents

Utilize many software programs, including: Microsoft Office, REDCap, Meditech, and Biological Systems Inventory

Clinical Research Specialist

Nov. 2005-June 2009

Avera McKennan

Collaborate with research coordinators, physicians, CROs and sponsor organizations throughout study procurement

Maintain database of potential and open studies

Create study source documents using Microsoft programs

Create subject databases for future and current research trials

Assist with scheduling patient visits for multiple clinical trials

Enter study visit data into sponsor electronic databases

Enter study visit data into databases for our Investigator initiated research trials.

Process study labs using Good Clinical Practice

Phone screen potential study subjects according to study inclusion/exclusion criteria

Coordinate duties for part time assistant

Promoted to Regulatory Specialist

Support Specialist

2004-2005

Avera McKennan

Diversified secretarial duties

Scheduling of daily activities

Retention and organization of documentation

Follow-up functions for office staff members

Coordinates Director’s schedule and appointments

Schedules and resources the Foundation Board: meetings, committee meetings, arranges for rooms, meals, equipment, etc., minute taking, agendas, etc. in an accurate and timely fashion

Assists with processing all community sponsorships and gifts made and tracks these on a spreadsheet

Assists with processing all requests for funds submitted for patient, family, employee and department assistance

Track product sales and inventory

Health Unit Coordinator

2003-2004

Avera McKennan

Scheduling surgery procedures

Track surgical procedures to keep the flow moving seamlessly

Creating and implementing new databases for the Surgery Department

Inside Sales Representative

1997-2003

Inter-Tel Datanet

Work with a wide variety of information systems, such as Microsoft Word and Excel, Novell, Cisco, Nortel, Compaq, Hewlett Packard, and IBM

Solved customer issues, answered product questions and configured new solutions for clients • Liaison between the client, sales rep, and the service department

Creating Excel spreadsheets and business documents

Configure service agreements for client’s hardware

Filing, data entry, and 10-key

Purchasing and receptionist backup

Answered the switchboard, distributed mail and faxes, and checked in hardware for repair

Configured IS equipment for multiple accounts

Resolve customer relation problems

EDUCATION

2008

Online – Axia College of University of Phoenix

Associates in Healthcare Administration

CERTIFICATIONS

CITI Human Subject Research – AIHG

CITI Good Clinical Practices – Clinical Drug 2014-2021

CITI Human Subject Research – Clinical Drug 2016-2021

IATA (International Air Transport Association) certified 2016-2018

IATA (International Air Transport Association) certified 2018-2020

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