Karly Morkes

Managed and monitored over twenty clinical research sites performing FDA-cleared Xoft® Axxent® Electronic Brachytherapy (eBx®) System® to treat early-stage breast cancer. Collaborated with over fifty site personnel to resolve data and regulatory discrepancies and ensured data integrity through accurate and complete source document verification and query issuance.

Managed sixteen or more oncology research sites throughout the drug development and clinical trial process for a global Clinical Research Organization (CRO). Oversaw clinical operations of assigned sites, fostering strong relationships with site personnel to ensure clinical trials were executed correctly and critical client deadlines were achieved.

Managed reimbursements, expenses, and revenue totaling over $6,000,000.00 for twenty clinical trial sites through accurate budget analysis. Provided managerial and administrative support for five complex clinical trial projects to ensure effective clinical trial team operations.

Supported Global Site Services (GSS) and Drug Safety Services (DSS) in clinical trial operations, helping ensure the integrity of document collection processing. Analyzed inconsistencies between Covance’s electronic master file and trial management system.

Conducted DNA extractions, enzymatic assays, and sequencing for investigating specific mutations using PCR and gel electrophoresis. Isolated and screened microorganisms to execute bacterial transductions while maintaining laboratory safety standards.

Reviewed and critiqued research literature for publication and conferences for the American Journal of Engineering Education. Authored and edited federal grant proposals for the Experimental Vehicle Program (EVP) and Master of Science in Professional Science (MS-PS) program.

Supported reporting chemist to conduct data research analyses and experiments on organic and inorganic substances to determine and evaluate chemical properties. Assisted in manufacturing, formulating, and producing fracture structural adhesives for various car companies, while maintaining profit margin by lowering the cost of raw materials by 20%.

Activities and societies: Member of the Grand Valley State Coed Cheerleading Team, achieving top three at Nationals in 2013.

Earned a Bachelor of Science in Biomedical Science. Maintained Dean's List while balancing academic rigor with participation in collegiate cheerleading.

Activities and societies: President of the Master of Science in Professional Science Club, organizing networking opportunities and attending conferences.

Completed a Master of Science in Professional Science with a specialization in Biotechnology. Engaged in graduate research as an assistant, reviewing literature, authoring grant proposals, and conducting laboratory experiments.