Amsterdam, North Holland, Netherlands
I am a certified Project Management Professional with nearly 10 years of experience delivering on-target, high quality outcomes for three Clinical Research Organizations, where I have managed complex, multi-year projects in North America, Latin America, Europe and Asia Pacific.
Responsibilities include coordinating pharmaceutical clinical trials per sponsor protocol criteria, collaborating and communicating with medical professionals, project managers, monitors, team members, and other clinic personnel to ensure accurate and high-quality results, reviewing all study-related data to confirm protocol compliance, ordering supplies, coordinating specimen shipment, dosing subjects with investigational products, review, update, and verification of adverse events, and following GCPs.
My primary responsibility as a recruiter for PPD was screening subjects to ensure they could safely participate in Phase I research studies per FDA guidelines. This process began with interpreting sponsor company protocols to determine what aspects of the subject's health needed to be assessed, such as blood pressure ranges, ECG parameters and medical history. Using company software, I created a profile for each study to ensure all aspects of the inclusion/exclusion criteria and other client-dictated requirements were covered during the screening period. Once created, I set dates for screenings that I conducted and a separate visit where the Principal Investigator conducted a physical exam and review of the subjects' medical history. As part of a research team, I assisted with other aspects of the Phase I Clinic necessary to study conduction, such administering investigation products, verifying data collection sheets and preparing clinical supplies (blood collection tubes, urine collection containers, etc.). A few major skills essential to my success as a recruiter were consistency, accuracy and problem solving. My diligent review of all documents I produced and submitted as well as consistent and accurate practices in performing my position's responsibilities resulted in very few findings by internal and external audits. For example, the first study I recruited resulted in zero total findings from PPD's Quality Assurance department. Overall, my work as a recruiter gave me a strong understanding of how Phase I pharmaceutical trials are set up and conducted, as well as FDA and ICH, GCP and GDP guidelines.
My duties with Regency included proving care for 10-12 residents with care levels from independent to total dependent. Specifically, I assisted residents with their activities of daily living, such as personal hygiene, serving meals and helping residents feed themselves, ambulation, toileting and turning and positioning. Additionally, I assisted with passing snacks, monitoring patient stability by observing vital signs, weight and reporting intake and output information and passing water. After two months of working as a CNA, I was promoted to hall coordinator. As a hall coordinator, I was responsible for ensuring all CNAs on my hall arrived to work on time, notifying the nurse of any absent CNAs and ensuring CNAs complete their duties (passing snacks and water, recording vital signs). Moreover, I completed and passed out all shower assignments to the CNAs on my hall prior to each shift and completed rounds with the departing CNA at the beginning of my shift and the oncoming CNA at the end of my shift. Due to my hard work and diligence, I was awarded employee of the month of May after only three months of experience as a CNA and with working at Regency.
At Travis Medical, I correspond daily and interact with case managers and discharge planners in regards to durable medical equipment needs for discharging patients. A major aspect of this position is educating case managers and clients alike on the rules and guidelines set by their insurance providers, most commonly Medicare and Medicaid. It is also my responsibility to ensure all necessary paperwork is collected and archived before creating a delivery ticket with industry-specific software and coordinating delivery of equipment. Additional duties include assisting the retail floor division with walk-in customers and general inquiries and answering all incoming phone calls.