DONCHEL BOONE

• Monitored clinical trial phases I-III, ensuring compliance with Good Clinical Practice, investigator integrity and study procedures
• Maintained metrics of 8 days on site per month per CRO requirements

Therapeutic area: Infectious Disease - Children living with HIV 1: Managed 8 sites total and conducted over 150 site visits which included pre-selection visits, site initiation visits, interim monitoring visits and close-out visits according to monitoring plans

• Completed site monitoring visits reports with 5 days of site visit
• Performed IP accountability and IP destruction based on sponsor and CRO specific procedures
• Maintained electronic trial master file (eTMF) and investigator site file (ISF) for audit readiness
• Issued/closed queries, pulled query reports and assisted sites with answering queries
• Issued/closed action items and assisted sites with answering action items
• Supported site preparation for sponsor audits, documented protocol deviations, and adverse events
• Using the electronic data capture system (EDC) to perform source data verification/review (SDV/SDR) for reliable results, originality and protocol adherence
• In addition to ensuring GCP guidelines and ALCOA principles are being followed to maintain integrity and quality of data
• Created CAPA plans or assisted sites with CAPA plans as well as re-trained site on protocol if applicable

Therapeutic area: Rare Disease - Babies who are suffering from Biliary Artesia: Managed and performed monthly site monitoring calls for 13 sites

• Maintained eTMF for study, closed action items and queries
• Documented and reported temperature excursions, protocol deviations and adverse events
• Completed site monitoring call reports within 5 days of calls

Unblinded CRA for Pediatric pneumococcal vaccine study: Overseeing site adherence to blinding plans, IP handling, IP storage and IP distribution

• Ensured that sites receive IP
• Provided the site with IP temperature excursion form if temperature monitoring device was defective or if temperature was not maintained during shipment to site
• Provided sites with IP documentation such as temperature monitoring device forms, temperature excursion forms, IP accountability forms and IP logs
• Performed onsite uSIVs and IMVs

In-house CRA for Oncology studies: Breast and Lung Cancer Managed eTMF and pulled query reports for sites assigned

• Collected lab normal ranges for study participants and created excel sheets of collected results for study team
• Performed site management duties including the closing of queries, action items and assistance with protocol adherence
• Utilized protocol deviation reports to update, close or remove protocol deviations

Therapeutic area: Infectious Disease - Covid-19

• Adhered to standards in all areas, including data collection (EDC), research protocols and regulatory reporting
• Collected, processed, and shipped biological samples from trial participants while maintaining safety compliance
• Collaborated with investigators and study team to carry out efficient and fully compliant research trials
• Obtained informed consent from participants and guardians to explain possible side-effects and potential outcomes of clinical research
• Conducted study visits according to protocol, including vital sign collection, blood draw for biological samples and scheduling follow-up visits
• Recruited participants within hospital and from a filtered subject recruitment database list
• Accessed adverse events by categorizing them by grade and ensured the PI signed and dated labs in real time
• Maintained subject binder, ISF and ensure quality assurance by performing quality checks in electronic data capture
• Managed other clinical research coordinators and worked directly with regulatory staff to ensure study documents were always audit ready

• Performed cell line genetic characterization using western blotting to support cell line specific proteins
• Created hypotheses in support of the role of myosin light chain kinase and its correlation with tumor progression
• Followed specific protocol to create cell growth medium for cell culturing production by using fetal bovine serum
• Analyzed, evaluated and solved problems using the scientific method and laboratory safety procedures
• Developed methodologies for short- and long-range objectives for the indoor growth of industrial watering and fertilizing programs to maintain approximately 100 industrials hemp plants
• Communicated entomology findings using written and oral reports
• Ensured worker safety including training, supervision, and control of safety guidelines.
• Performed over thousands of identity and classification tests for arthropods according to guilds by using stereoscope
• Conducted qualitative and quantitative statistical research using Analysis of Variance (ANOVA) analysis software

• Prepared the autopheresis machine for the pheresis process, disconnected the donor from the needle and followed all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures
• Performed venipuncture and skin puncture procedures to collect blood samples from donors
• Ensured that all donor safety protocols are followed, including the use of personal protective equipment (PPE)
• Maintained a clean and safe work environment by adhering to CSL Plasma's standard operating procedures
• Monitored pheresis procedures, responding to adverse events, and prepared specimens for shipment, delivering high-quality customer service throughout donor interactions