Experience

WEP Clinical

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Document Specialist

  • Aug 2021 - Present



The North Carolina Community of Hearts and Homes

• Raleigh-Durham, North Carolina Area

• President Of The Board Of Directors

  • Apr 2018 - Present

  Our vision is a master planned community to lift up the chronically homeless in the greater Raleigh area in to a community where they can live, work and enjoy fellowship in a safe community. We will have many amenities to help the homeless heal and we hope to encourage volunteers in to a life style of service with the homeless. Our vision is a master planned community to lift up the chronically homeless in the greater Raleigh area in to a community where they can live, work and enjoy fellowship in a safe community. We will have many amenities to help the homeless heal and we hope to encourage volunteers in to a life style of service with the homeless.



Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

• Morrisville, NC

• TMF Document Specialist II

  • Jan 2018 - Jul 2021

  TMF Document Specialist II • Process clinical study documentation in accordance with SOP's, OG's, GCP's and ICH Guidelines • Support set-up, maintenance, and closure of Trial Master File (TMF) repositories. • Support documentation collection activities, including document scanning and indexing for trial using eTMF, electronic systems being used most are Veeva Vault, and Trial Interactive, document filing for trials using pTMF. Perform Secondary QC in Veeva and end of study export. • Perform content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. • Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate. • Support the inventory and transfer of trial master files to clients at the conclusion of trials including export of electronic files. • Provide guidance/training to team members on departmental processes. • Complete assignments on-time and on-budget and administrative tasks (e.g. status reports) as requested. • Maintain compliance with company requirements (e.g., time tracking, SOP's). Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• TMF Document Specialist II

  • Jan 2018 - Jul 2021

  Highlights include working in multiple systems for eTMF including Veeva Vault, Trial Interactive, Documentum and using multiple file structures for pTMF. I have been involved in paper studies from file setup, through maintenance, closeout and transfer to client. In Veeva I have been involved in maintenance, secondary QC, export of electronic documents at closeout and transfer to client. Highlights include working in multiple systems for eTMF including Veeva Vault, Trial Interactive, Documentum and using multiple file structures for pTMF. I have been involved in paper studies from file setup, through maintenance, closeout and transfer to client. In Veeva I have been involved in maintenance, secondary QC, export of electronic documents at closeout and transfer to client.



inVentiv Health Clinical

• Cary NC

• Document Management Associate I

  • Aug 2015 - Dec 2017

  Document Management Associate I • Process clinical study documentation in accordance with SOP's, OG's, GCP's and ICH Guidelines. • Support set-up, maintenance, and closure of Trial Master File (TMF) repositories. • Support documentation collection activities, including document scanning and indexing for trial using eTMF, document filing for trials using pTMF. • Perform content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. • Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate. • Support the inventory and transfer of trial master files to clients at the conclusion of trials. • Complete assignments on-time and on-budget and administrative tasks (e.g. status reports) as requested. • Maintain compliance with company requirements (e.g., time tracking, SOP's). Show less



Mii Sashi Petsitting

• Owner

  • Oct 2010 - Sep 2016

  Owner and Operator of Mii Sashi Pet Sitting specializing in cats but working also with dogs, rabbits, rodents, fish and birds primarily in Garner and Raleigh. Employees now covering Willow Springs, Garner, north Raleigh, Wakefield and Wake Forest as well. Owner and Operator of Mii Sashi Pet Sitting specializing in cats but working also with dogs, rabbits, rodents, fish and birds primarily in Garner and Raleigh. Employees now covering Willow Springs, Garner, north Raleigh, Wakefield and Wake Forest as well.



SAFE Haven for Cats

• • Aug 2010 - Jan 2015

  Clinic Administrator • Scheduled the Spay/Neuter Clinic clients• Answered phone• Greeted clients, donors and assisted the public• Billed voucher programs and rescue groups using Clinic HQ• Data entry into Clinic HQ, Access and Etapestry

• • Jun 2010 - Aug 2010

  Care of cats in isolation areas.



North Carolina State University

• Raleigh, NC

• Research Operations Manager

  • Jul 2007 - Oct 2009

  Research Operations Manager • Planned and delegated work for technicians, supervisors and assistant manager • Worked closely with research staff to facilitate planning of animal studies including space allocation • Developed and updated SOP’s, assure compliance with policies, procedures and regulations • Involved with facility designs alterations and renovations, personnel issues, budget, billing and cost accounting • Interviewed potential candidates, assisted in developing recruitment notices and providing input with promotional and salary administration decisions • Was responsible for vehicle and equipment maintenance • Responsible for coordinating training of technical staff and promoting AALAS certification • Provided direct animal care when needed with a variety of species including birds, domestic farm animals, companion animals, alpacas, fish and wildlife Show less