Experience

AMPEL BioSolutions

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Clinical Research Associate

  • Jun 2018 - Present



DSP Clinical Research

• United States
• Professional Services
• 1 - 100 Employee

• Senior Clinical Research Associate

  • Jun 2015 - Jun 2018

  • Conduct pre-study, initiation, interim and closeout visits for Phase I-IV studies across the US and Canada. • Responsible for managing all aspects of Phase I-IV projects with assistance from the in-house team. • Verify data on electronic case report forms (eCRFs) and collect essential documents for trial master file (TMF) filing. • Prepare and submit monitoring reports in a timely manner. • Conduct pre-study, initiation, interim and closeout visits for Phase I-IV studies across the US and Canada. • Responsible for managing all aspects of Phase I-IV projects with assistance from the in-house team. • Verify data on electronic case report forms (eCRFs) and collect essential documents for trial master file (TMF) filing. • Prepare and submit monitoring reports in a timely manner.



Jaeb Center for Health Research

• Protocol Monitor

  • Dec 2013 - May 2015

  • Performed management of study site activities to ensure the integrity of clinical data, in compliance with regulatory requirements and ICH/GCP. • Participated in the study development and start-up process including designing and/or reviewing eCRF, prepare informed consent forms, develop study documents, train and certify sites. • Conducted remote site management activities (i.e. review data, post/resolve queries and review informed consent forms) • Performed on-site monitoring • Assisted with IRB submissions, applications and consent revisions • Acted as liaison between the T1D Exchange Coordinating Center for multiple sites during the study regulatory and start-up process Show less



DSP Clinical Research

• United States
• Professional Services
• 1 - 100 Employee

• Manager, Quality Assurance & Training

  • Jan 2013 - Nov 2013

  • Under minimal supervision, provide overall management for domestic and/or international projects for one or more clients, according to the approved Clinical Trial Agreement, DSP Standard Operating Procedures, ICH Guidelines and applicable regulations. • Provide performance feedback of team members to upper management and/or appropriate line managers and resolve conflicts as needed. • Assist with implementation of operational activities to increase quality, productivity and efficiency of the functions of DSP.• Assures the proper planning, conduct and reporting of clinical quality management audits and prepare for and manage regulatory inspections.• Perform quality checks of study operations activities to ensure study team is adhering to company and Client’s policies and procedures. • Assist with other external quality audits of external vendors as needed. Show less

• Assistant Project Manager

  • Sep 2011 - Jan 2013

  • Managed projects within agreed upon timelines, budget and project scope of work. • Reviewed and evaluated study metrics and ensured deliverables were met. Served as primary contact for clients, vendors and other key project team.• Conducted monitoring and/or co-monitoring visits (pre-study, initiation, interim and close-out) when needed by the study team.

• Clinical Research Associate (In-house)

  • Sep 2008 - Sep 2011

  • Accountable for providing regulatory documentation to support study start up activities, including all site supplies and site grant payment process. • Acted as secondary liaison for assigned study sites to convey project information and help resolve site related issues.• Ensured all regulatory documents and study supplies are maintained during the life-cycle of any assigned project in collaboration with the assigned Regional Monitor.

• Clinical Assistant

  • Nov 2007 - Sep 2008

  • Responsible for the review and tracking of site regulatory documents and submission to the central IRB and internal regulatory department. • Prepared and tracked confidentiality agreements and investigator grant agreements.• Administrative tasks included: Coordinated Investigator Meeting travel arrangements, mass mailings to investigator sites and Monitors, and facilitated investigator grant and vendor payments.