Experience

Janssen Research & Development, LLC
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Functional Manager - Cross TA - Janssen Research & Development, LLC

  • Nov 2022 - Present


Johnson & Johnson

• Law Practice
• 1 - 100 Employee

• Local Trial Manager - Clinical Research Specialist

  • Sep 2008 - Apr 2023

  •Built excellent working relationships with site managers, other local trial managers, and global management team to ensure success of trials•Mentor and guide new LTMs and SMs. Participate and present at new hire trainings for both LTM and SMs. •Work as a champion for VTMF and VIPER systems. Assist colleagues in understanding the systems and available to answer questions when needed. •LTM Team Leader for VTMF New Hire Training •Started the Global Viper Champions group in 2018. Manage the meetings and point of contact for the Global Viper Champions. •Collaborate with team members to update and create training documents for New Hire Training.•Completed accompanied site visits and file reviews with site managers as part of a rotation•Prepare Sites for FDA Audits. Manage CAPAs after audits•Worked on file review and reconciliation for audits. Participated in war room activities during the FDA audit. •Perform country/site feasibility and summarize information in a Country Feasibility Report •Select USA sites for participation in trial•Work with GTM to set-up of investigator meetings and vendors•Assist in development of CRF modules, monitoring guidelines, pharmacy manual, and other study tools•Create and manage local trial budget•Ensure that SAEs and pregnancies are reported within appropriate timelines and according to procedures. •Manage shipment of drug and non-drug supplies is arranged and monitor the process •Create and update local ICF throughout the life of the trial•Submit regulatory documents to the central IRB. Ensure IRB receives all current documentation.•Manage the vendor s specific to USA – drug destruction, central IRB, other trial specific vendors•Review monitoring reports and ensure proper oversight at all USA sites. Ensure monitor frequency is in accordance to the guidelines•Participated in several database locks. Work with sites, monitors, and data management to ensure timely and accurate query resolution Show less



Centocor

• Biotechnology Research
• 400 - 500 Employee

• Clinical Research Associate

  • Sep 2006 - Sep 2008

  • Assist in creation of audit preparation training; Presented training to peers • Participated in mock FDA audit in preparation for BLA submission. Visit several sites in order to assist them in audit preparation (FDA, EMEA, and Health Canada). • Completed quality assurance corrective action plans for sites audited in the dermatology program • Took a lead role in coordinating the internal audit of the T08 and T09 archives in order to ensure a successful FDA audit • Perform site monitoring and qualification visits • Prepared site confirmation and follow up letters and monitoring reports • Generated data queries and worked directly with sites to resolve discrepancies • Mentor and train CR assistants in site monitoring. Accompany junior CRAs on monitoring visits • Responsible for co-monitoring with contract staff to ensure protocol and GCPs are followed • Oversee collection of essential regulatory documents from site and CRAs • Review monitoring reports for contract monitors (100% report review). Ensure outstanding issues are resolved • Manage Lab vendor, Quintiles, for several trials. Manage Strata requests from sites and monitors (binders, eCRFs) • Responsible for management of alert lab values. Liaison between medical monitors and site monitors for any additional information requested due to alert lab values • Edit and update informed consent documents; worked closely with sites, monitors, and IRBs Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Jul 2005 - Sep 2006

  • Communicated with and managed sites • Gathered all regulatory documentation needed for study startup and IRB approval • Maintained clinical study files • Reviewed informed consent documents • Completed initiation, monitoring, and close-out visits (traveled extensively) • Responsible for drug accountability • Generated and resolved queries • Completed SAE reconciliation and reviewed data listings • Communicated with and managed sites • Gathered all regulatory documentation needed for study startup and IRB approval • Maintained clinical study files • Reviewed informed consent documents • Completed initiation, monitoring, and close-out visits (traveled extensively) • Responsible for drug accountability • Generated and resolved queries • Completed SAE reconciliation and reviewed data listings