Oncology Trials- Coordinated study start up activities for PIs/Sites to meet greenlight target dates.- First point of contact for sites along with additional monitoring during bi-weekly site monitoring with study staff to ensure protocol adherence and progression.- Trained and clarified sites on proper protocol procedures and usage of EDC systems across 3rd party vendor portals. - Updated CTMS daily with new site contacts, accounts, document and regulatory tracking. - Reviewed pathology, hematology, UA, radiology scans among additional medical records to ensure subjects were enrolled per protocol criteria and continued safety reporting requirements were being meet.- Reviewed IND Safety Letters to inform sites of important safety updates for sites Local or Central IRB notification per site regulations. - Investigated poor enrollment accruement barriers and work with Sponsor and Site to reach study goals. - Assisted in meeting study requirement goals 3 months ahead of schedule.- Managed Clinical Study Data and resolve site queries in accordance with Data Management Team - data cleaning/lock per study milestones. Was able to compile numerous reports noting inconsistencies in EDC portal which reduced downstream auto edit check errors.- Provided and coordinated complex Protocol clarifications between Site and Medical Monitor Team as needed, which allowed faster TAT from pre-screen to enrollment. - Reviewed ICFs, Budgets, 1572s, Satellite Management Plans and regulatory documents. - Analyzed study data to find trending issues across the program studies to escalate and resolve in timely fashion to avoid recurrences throughout the study.

Oncology & Cardiovascular Study Experience:- Completed Covance’s CRA Foundations Monitoring Training and was successful in organizing, creating and facilitated CRA trainings for new hires.- Ensured compliance with Company SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.- Managed Temporary hires to ensure in-house and 3rd party vendor supplies reached sites prior to greenlight date. - Created, updated, tracked, and maintained study-specific trial management files, tools, and systems within timelines. General On-Site Monitoring Responsibilities:- Performed reviews of CRFs, Site Notebook, IP accountability and Safety Letter Acknowledgment from PI/ -- Regulatory Coordinator.- Routine monitoring of subject medical records to ensure data is correctly entered into studyportals and signed off from PI.- Query Generation and resolution against established Sponsor DM guidelines, while ensuring data milestones were complete in timely fashion. - Reviewed Training logs to train new site staff on proper protocol practices. - Create CAPAs for high risk sites and escalated all issues to CTM and PM for study transparency. - Performs other duties as assigned by management e.g. (TMF QC’s and review, packaging and shipping of client deliverables)

• Ensured over half dozen employees complied with medical ethics mandated by HIPPA.• Documented employees’ acknowledgement of OSHA and EPA regulations by administering online course completions. • Communicate appropriate treatment and financial planning between patients and office manager.• Manage clinical practice schedule and all operations pertaining to clinical activity, including assisting in restorative and surgical procedures. Increased patient enrollment by 33% in one month; via low customer acquisition cost marketing techniques.• Additional clerical duties as needed to accomplish an efficient work environment. • Ensure clinical and administrative equipment is adequately maintained, while managing the appropriate inventory of supplies needed. • Abide to strict professional ethics when explaining and documenting patient informed consent.

- Preparing class for days objectives - Scheduling additional teaching and lab study times - Proctoring exams - Grading exams

- Assist in all Dental procedures.- Train new dental assistants. - Coordinate with insurance and billing department to validate patient records and payments. - Confirm invoice and restocking of Dental materials and inventory.

- Medical Filing, answering phones, calling pharmacy's to relay patient prescriptions, 24hr Cardiac Holter Monitor Reading and analysis for arrhythmia, preparing items for shipping, medical data entry into electronic systems.