Susan Auler, Msc, Bsc, Pma, Cra, Crc, Rpt Email & Phone Number

Delray Beach, Fl, Us

Florida, United States

Submit serious adverse events, Investigational New Drug (IND) reports, protocol addenda, and other documents to Internal Review Boards by prescribed procedures. Prepare Institutional Review Board (IRB) review reports by prescribed procedures. Maintain and update IRB tracking databases; perform quality assurance reviews of the tracking database; maintain up-to-date comprehensive regulatory and/or study binders; maintain protocols, consents, and IRB documents. · Assist Research Administrators with clinical research trials by collecting protocol-required data from medical records, entering data in case report forms or into a computerized database, and maintaining case report forms in compliance with privacy laws. Provides sponsors with updated regulatory documents; performs regulatory quality assurance reviews of local and remote working files. Develop and implement research team procedures and assign duties to staff and the overall mission of the research department. Plan, schedule, and coordinate research team meetings that are needed to facilitate communication about and coordination of research activities. Interact with laboratories involved with research activity to ensure adherence to clinical protocols and to meet regulatory requirements. Identify potential participants for the studies and screen potential participants for eligibility. Work with study teams to develop new objectives, goals, and performance measures for the study; work closely with study teams to ensure that the study direction is implemented timely and effectively. Participate in designing new interventions, analyze the effectiveness of the program and the outcomes, and proposing innovative directions for the program. • Review specific job responsibilities with principal investigator (PI) for each protocol.

Maintaining an accurate inventory of pharmaceutical products, I complete a weekly stock count and then place orders as required for appropriate storage. I help with filling the prescriptions on approximately 800 to 1200 daily bases. I validate insurance information and claims plus resolve issues related to bills and insurance terms. Recording label and dosage inaccuracies and reporting to the pharmacist, I oversee an inventory of 1,500 products and serve a patient database of 4,000. Processing 2,500 insurance claims each month, I resolve insurance issues within 45 minutes and have improved the prescription accuracy rate by 80%.

During this time I took the opportunity to refresh courses on Clinical Research Associate competencies and garner further knowledge in project management software, G-Suite, Jira, Slack, and Microsoft Teams.

United States

Collecting and preparing specimens for physician's diagnosis, I uploaded patient information into the database and performed equipment maintenance, calibration, and quality control procedures on tissue processors. I handled 180 test specimens each week.

South Africa

Executing clinical research and collaborating with the Flavor Chemist, I enhanced the taste of a soya sachet. Developed a new product from an existing one, improved its nutritional value, and identified ingredients that help to meet FDA dietary standards.

South Africa

Operating a total organic carbon (TOC) analyzer, I expedited the analytical process for cleaning validation in clinical pharmaceutical products plus validated active pharmaceutical ingredients (APIs) and the removal of cross-contamination in products. Recording the number of organic molecules and/or contaminants in purified water, I completed 240 reports validating the removal of residue agents.

South Africa

Undertaking clinical research, clinical trials, projects, and data reporting for this leading contract research organization (CRO)., Screened, secured consent, and enrolled patients in clinical trials. Completing document and medical record reviews, Uploaded information into the database and promoted communication and time management across the function. Leading core file reviews and assisting with audits, ensuring appropriate protocols and the accountability of the Investigational Product (IP). Calibrating and maintaining devices to ensure the accuracy of information, I collected, tracked, and maintained regulatory documentation, required by ICH-GCP guidelines and authorities, throughout the clinical study. Executing site visits and building robust relationships with contacts at study sites, verified the integrity of clinical data, oversaw data correction, and executed the study in adherence to approved protocols, SOPs, GCP, industry standards, and governmental regulations. Safeguarding study participants by checking consent process compliance plus the maintenance and timely completion of the e-Trial Master File (eTMF) with relevant regulations, authored, updated, and secured study data, documentation, and reports. Training and monitoring the performance of the Clinical Research Assistant (CRA), I ensured full understanding and delivery of project requirements. I prepared study-related materials and distributed to the CRA. Processing payments to vendors, consultants, and sites, collaborated cross-functionally to realize deliverables on time, on budget, and to agreed specifications. Coordinated the upgrade and review of clinical trial management tracking systems (CTMS) and collaborated cross-functionally with the global team assigned to clinical trials. Had the opportunity to understand various levels of Clinical Trials including PMA, CRA positions, Clinical Trial Assistant, Clinical Research Coordinator, Clinical Research Associate, and Project Management Analyst.

United States

Organizing a variety of events, including the University's Nursing Open House, White Coat Ceremony, Nursing Convention, and Wellness Center functions, I planned and coordinated occasions attended by up to 2000 guests.

United States

Assisted in preparation and maintenance of experimental reagent and laboratory supplies and practiced good clinical practices (GCP). Prepared gene clones by isolating RNA from HeLa cell, RT-PCR, and gene insertion in plasmid and transformation of bacterial culture.Conducted research in the following areas: Molecular Biology: DNA isolation from bacteria and mammalian cells, gene, and recombinant DNA cloning, gene amplification by PCR, RT-PCR, qRT-PCR, extraction of RNA from HeLa and HO-1 melanoma cell, PCR array, and data analysis, yeast two-hybrid system. Cell Biology: tissue culture and in vitro drug dosage, DNA and RNA transfection, florescent microscopy, cell lysis techniques, multiwall plate-based proliferation assays. Protein Chemistry: protein expression and purification, separation of proteins by FPLC, protein quantification assay, SDS-PAGE, western blot, High-Performance Liquid Chromatography (HPLC) ELISA, basic knowledge of mass spectroscopy, and NMR protein analysis.