Linda Charles

Experience

• 

  University of Michigan

  Jan 1992 - Jan 2000

  Laboratory manager, designed and applied protocols for the development of a prostate cancer vaccine, maintained records, trained new hires and students, maintained OSHA compliance. Laboratory manager, Bench top researcher, maintatined records, trained new hhires and students in laboratory procedures.

  • Research Associate II

    Jan 1995 - Jan 2000

  • Research Associate I

    Jan 1992 - Jan 1995
• 

  University of Michigan

  Sept 2005 - Sept 2005

  Research Associate II

  Temporary reseach position, animal surgey, biochemical assays

• 

  Innovative Biotherapies

  Jan 2006 - Jan 2018

  Research Associate

  Conducted basic and applied research to assess a biomedical device for acute and chronic conditions, in support of FDA IDE & 510k regulatory pathways. Updated CRFs, filed FDA correspondence, prepared annual reports for granting agency, QC for clinical trial medical device units, prepared experimental kits, flow charts and logs for clinical trial, developed various databases (inventories, data analysis, specimen storage), developed SOPs, developed laboratory safety manual, trained new hires and students. Show less

• 

  Michigan Medicine, Oncolgy Clinical Trials Support Unit, NCTN LAPS team manager.

  Jan 2020 - now

  Clinical Research Coordinator - Project Manager
• 

  Michigan Medicine

  Jan 2020 - Jul 2022

  Clinical Research Coordinator-Senior Lead

  Data Management and Regulatory responsibilities-Mentor new hires on LAPS processes and general duties for clinical research coordinators.-Prepare and present Site Initiation Visits.-Work directly with the clinic CRC and investigators managing subject data in the therapeutic area of Oncology – Breast, GI, Brain, MATCH (targeted therapy, metastases).-Assess eligibility of subject for trial participation.-Enroll subject in trial (OPEN system).-Enter subject data on a timely basis in an EDC system.-Manage data in EDC for trials associated with Alliance clinical trials in cancer, ECOG-ACRIN cancer group, NRG-oncology and SWOG.-Assess SAEs and AEs using source documents and CTCAE guidelines. Assign severity and relatedness of AEs and SAEs to treatment, working directly with investigator.-Maintain electronic files and paper file source documents on each subject in a timely manner.-Prepare and submit regulatory documents to the local IRB; staff change amendments, schedule continuing reviews, termination reports, SAEs and Other Reportable Information and Occurrences (ORIOs).-Review and update study protocol changes with regulatory personnel.-Report AEs, SAEs, and breaches to CIRB.-Draft CTEP-AERS reports, confer with PI and submit.-Generate Study Specific Worksheets (SSW) for the CIRB when Principal Investigators open new trials.-Upload documents to TRIAD, AgMedNet, Bioclinica and iMedidata Source Document Portal.-Generate Delegation of Task Logs (DTL), both paper and electronic (DTL administrator for NCI sponsored trials).-Order trial kits, paper Quality of Life booklets, and Neurocognitive booklets.-Prepare shipping manifest for study trial specimens. Show less

• 

  University of Michigan -OCTSU

  Jul 2022 - Sept 2024

  Clinical research Coordinator Lead, LAPS NCTN Manager