Erin Klintworth

Experience

• 

  Medical University of South Carolina

  Dec 2006 - now

  - Develop and manage a comprehensive research compliance program within the SCTR Research Coordination and Management Program.- Independently perform quality assurance review of study documents and data across multiple complex studies to ensure subject safety, data validity, and compliance with internal SOPs, regulations, and sponsor requirements.- Develop and disseminate corrective action plans for improved clinical trial performance/compliance.- Serve as subject matter expert for division staff for questions/issues related to study documentation, good clinical practice, and regulations. Show less - Develop and coordinate project specific data management procedures. Provide comprehensive guidance and training to collaborators regarding data management for assigned projects.- Develop and maintain study specific documents, such as case report forms, Manual of Procedures, study protocols, data management plans, user manuals, and data collection guidelines.- Manage the activities of external Clinical Research Associates and oversee the proper budgeting and invoicing of their site monitoring trips.- Manage and coordinate study drug accountability processes and shipments from the central pharmacy to participating sites.- Manage data querying and quality procedures including review of submitted case report forms and generation of data queries.- Manage the collection and verification of regulatory and essential documents and manage communications with regulatory authorities.- Coordinate study meetings and provide information regarding resource allocation and needs. Show less - Serve as institutional subject matter expert regarding research regulations.- Consulted with research faculty and staff on subject matter such as: regulatory submission processes, compliance with applicable regulations and Good Clinical Practice guidelines, protocol development, consent document development.- Train research faculty and staff on regulatory issues- Develop content for and presented biannual lecture on "Essential Documents" for clinical trials as part of MUSC's Core Clinical Research Training course.- Collaborate with institutional offices to develop policies and tools for the research community. Show less - Assist with the management and training of a team of Clinical Research Coordinators and Nurse Coordinators providing services to multiple clinical departments. - Manage research activities of MUSC's Department of Radiology, including: pre-award management of site selection and contracting processes, regulatory submissions and documentation, as well as post-award activities including visit coordination, overseeing day-to-day study operations and overseeing research personnel hiring and training. - Provide consultation to research teams related to the management and conduct of research studies in compliance with federal, state and MUSC policy and Good Clinical Practice standards. Show less - Serve as project manager/CRA for multiple clinical research studies being conducted at clinical sites around the state. - Prepare sites for study implementation, including: identifying recruitment plans, coordination and tracking of required training, developing of site specific operating procedures, and conducting protocol “walk thrus” with the site to ensure appropriate knowledge of all procedures prior to study implementation. - Act as a liaison between the research site, lead investigative team and the sponsor’s coordinating center.- Serve as local contact and “protocol expert” for sites, providing guidance on protocol procedures, regulatory procedures, and documentation. Lead weekly local protocol conference calls with study sites. - Perform pre-initiation, interim, and close-out monitoring visits ensuring the site’s compliance with the protocol, SOPs, federal, state and local regulations. Complete monitoring reports for distribution to the lead investigator, sponsor, local PI and site. - Provide feedback to the study team regarding findings of monitoring visits. Identify and provide additional training as required. Show less - Manage all operations of multiple clinical trials. - Manage data collection/entry and prepare status reports for research team as necessary - Complete regulatory documentation and monitor documentation for compliance with research protocol. - Assessment of research participants for study entrance criteria per research protocol - Assist in hiring and training of new research staffProtocols Managed:- A Randomized Double Blind Pilot Study of the Safety and Efficacy of Varenicline vs Bupropion XL in Adolescent Smokers (December 2008 – July 2010) - Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity (October 2008 – July 2010)- Combined Pharmaco/Behavior Therapy in Adolescent Smokers (December 2006 – May 2009) Show less

  • Quality Assurance Program Manager

    Jul 2019 - now

  • Clinical Research Project Manager and Data Manager

    Feb 2016 - Jul 2019

  • Regulatory Knowledge and Support Core Manager

    Sept 2013 - Feb 2016

  • Clinical Research Project Manager

    Sept 2012 - Aug 2013

  • Clinical Research Associate

    Jul 2010 - Jan 2013

  • Clinical Research Coordinator

    Dec 2006 - Jul 2010