Experience

Arete Biosciences, Inc

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• • Jul 2023 - Present

  • Lead a team of clinical professionals to deliver quality clinical research oversight and results• Foster relationships & collaborate with clients to support clinical trial needs• Provide guidance on clinical site selection dependent on study design• Oversee clinical trial activities from site qualification, initiation, monitoring, through study completion • Mentor clinical personnel of varying backgrounds • Work with clients to provide GCP oversight and compliance to existing clinical departmental procedures Show less

• • Aug 2021 - Jul 2023

  • Foster relationships & collaborate with clients to support clinical trial needs• Provide guidance on clinical site selection dependent on study design• Oversee clinical trial activities from site qualification, initiation, monitoring, through study completion • Mentor clinical personnel of varying backgrounds • Develop study protocols and operating procedures to uphold study integrity• Review clinical trial data to support clinical study reporting • Manage clinical trial resources and timelines in coordination with project teams Show less



Luminex Corporation

• United States
• Biotechnology Research
• 700 & Above Employee

• • Oct 2020 - Aug 2021

  • Manage clinical trials from site qualification through study completion and site closure, in compliance with applicable regulations and standards • Develop study protocols and departmental SOPs • Prepare clinical study final reports• Supervise collection and tracking of clinical study specimens• Monitor adherence to protocols during clinical studies and determine study completion• Interact with internal and external groups to facilitate completion of studies for IVD regulatory submissions• Present clinical study status updates to management Show less

• • Mar 2017 - Oct 2020

  • Day-to-day hands-on work associated with in-house clinical studies• Collection and analysis of experimental data generated in-house and externally• Prepare monitoring reports and letters per defined timelines • Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out• Reconcile site regulatory binder and file documents as needed• Train and provide technical support to external sites• Mentor entry-level team members in departmental procedures and regulations Show less

• • May 2016 - Mar 2017

  • Management of clinical samples used to support regulatory submissions• Acquisition of samples from external clinical sites to build the sample bank• Interdepartmental requests for clinical samples • Maintain electronic database of all clinical samples

• • Aug 2015 - May 2016

  • Manage inventory and logistics of shipping supplies and samples to external testing sites• Assist in preparation and qualification of samples for internal clinical validation studies • Departmental document creation and control• Regulatory departmental support through document preparation and compliance matters


University of Illinois at Urbana-Champaign
• Higher Education
• 1 - 100 Employee
• Medical Entomology Lab Assistant

  • Jun 2006 - May 2014