Clinical Research Director of Auditing and Quality Assurance

• Jan 2023 - Present

Clinical Research Auditor

• Jul 2021 - Sep 2022

Clinical Research Audit Specialist

• Mar 2020 - Jul 2021

Senior Clinical Research Director

• Oct 2018 - Jan 2020

Senior Oncology Clinical Research Coordinator

• Jan 2018 - Oct 2018

• Performs regular audits to ensure that the data that has been collected per clinical trial is complete and accurate to ensure that the protocol has been specifically followed. • Ensures that research protocols are approved by the Institutional Review Board/Privacy Board (IRB/PB) and maintains documents with amendments, updates, and sponsor correspondence. • Creates original SOP documents to enhance efficiency to facilitate data collection per protocol within a timely fashion. • Serves as primary contact for all levels of staff and sponsor by proactively addressing data entry issues, facilitating database enhancements and overseeing special requests. • Attends departmental research meetings and service trainings as required for projects, as well as perform trainings as needed. • Designs, coordinates, and implements all activities required to initiate, monitor, and close clinical studies that are well designed and scientifically valid. Show less

Oncology-Hematology-Medicine Clinical Research Coordinator

• Mar 2016 - Sep 2017

• Responsible for coordination of a specified study or multiple studies in a clinical or laboratory based research project where I follow clinical research procedures that includes recruitment of subjects, implementation of study guidelines, and the collecting, processing, and analysis of data. • Works to ensure that multiple trials are conducted in adherence to study protocols, correct SOPs, FDA regulations, and strictly follow ICH/GCP guidelines. Creates documents for clinical trial related documents to ensure that all protocol regulations are followed, and completes start-ups, conducts, and closeout visits for clinical trials. • Throughout clinical research, ensures the safety and comfort of patients being evaluated. Supervises the scheduling of patients for clinical and biological laboratory evaluations, and sets up educational workshops for patients and families so that they are informed of all procedures. • Administers and scores assessments such as functional disability ratings, side effects evaluations, neurocognitive measuring, and other clinical ratings. • In clinical studies acts as liaison between the cooperative group and private pharmaceutical drug companies on related issues as well as follow specific specimen packaging procedures to ensure proper delivery to the specified locations. • Prepares and conducts multiple monthly meetings to ensure that all clinical trials are being managed correctly by creating agendas, tracking and screening patients through enrollment logs, maintaining study statuses and amendments. • Learns new protocols and is able to quickly adjust and communicate with different parties ranging in clinical oncology trials that consist of lung, head, neck, gastrointestinal, melanoma, genitourinary, sarcoma, and etc. Show less

Medical Administrative Coordinator

• Jul 2014 - Mar 2016

• Performed qualitative duties related to clinical services including medical transcription, composition, and dictation in medical group. • Maintained patient files, assisted in establishing office system and protocol, and provided correspondence to multiple medical offices. • Processed prescriptions using electronic medical records and private prescribing company. • Reviewed and ordered labs, notify prescriber of any abnormal labs that required immediate attention. • Provided coordination of care with clients, prescribers, including documentation of medical medications, dosing, and physical diagnoses. • Have a thorough understanding of how trauma impacts the lives of the patients, so that every interaction is consistent with the recovery process and reduces the possibility of traumatization. Show less

CEO

• Jan 2015 - Jan 2016

• Carried out necessary job functions such as emails and correspondence utilizing Microsoft Office. • Established positive client relationships by fielding initial calls from prospective clients with data entry and listing of activity logs. • Organized and maintained client files to ensure current information on prospective buyers. • Carried out necessary job functions such as emails and correspondence utilizing Microsoft Office. • Established positive client relationships by fielding initial calls from prospective clients with data entry and listing of activity logs. • Organized and maintained client files to ensure current information on prospective buyers.

Social Media Marketing Manager

• Jan 2014 - Jan 2015

• Managed and monitored various social media outlets for differing businesses in order to properly advertise events and activities. • Efficiently prepared and updated social media applications on a daily basis, organized information, and performed communications with various businesses. • Provided foundations fort social media planning, community building, and promotions. • Managed and monitored various social media outlets for differing businesses in order to properly advertise events and activities. • Efficiently prepared and updated social media applications on a daily basis, organized information, and performed communications with various businesses. • Provided foundations fort social media planning, community building, and promotions.