Paola M.

Maintain study documents, binders, manuals, and supplies to ensure adequate inventory for Clinical Operations and clinical sites Efficiently developed, maintained and managed study documentation, TMF. Managed and tracked study specific payment for sites and vendors. Managed and tracked clinical and non-clinical supplies. Ensured timely safety reporting was done. Maintain databases and tracking systems and review reports from various data sources (including the EDC and CTMS (Clinical Trial Management System). Maintain quality records and documentation for ensuring compliance with FDA regulations, ICH guidelines, and company SOPs and guidelines. Site Training (PSV, SIV) Responsible for obtaining, reviewing and approving Regulatory documents from sites such as FDA 1572s, 3455, Debarment Checks, W-9s, feasibly documents, etc. Verified Source documents against CRFs for Protocol deviations and accurate completion. Handled OC RDC reports and followed with sites for several protocols; 40 + sites to assure compliance. Site Monitoring Visits (SMV) i.e., pre study, initial, routine, close out visits. Efficiently tracked regulatory documents, contracts CTAs for in-house management of documentation and assisted with site start-up and close-out activities. Managed Confidentiality Disclosure Agreement CDAs with sites until fully executed.

New hire training: organizing orientation with an overview of the company’s beliefs and standards New hire documentation quality assurance Creating and implementing new training methods Presented created material to regional directors Cashier trainer: teaching cash handling and store policies Front End Supervisor Assisted in creating weekly schedules for over 50 people Working with a budget, ordering materials and keeping inventory Responsible for handling, balancing high cash volume and producing detailed financial reports Implemented regulatory audits to ensure total compliance Mediating and communicating between management and team members Scheduling weekly management meetings Great customer service Collaborated with other managers and leadership to create and review established goals

Properly consented subjects Obtained subjects anthropometric measurements Verified source data against CRFs Accurately entered CRF data into EDC system Assisted in marketing for patient recruitment Assisted in IRB submission matters

Treatment Coordinator/Administrator Greeting patients, collecting vital signs and documenting patients’ medical records Extensive phone usage: checking up on patients after procedures, scheduling appointments Informing patients of treatment procedures and adequately obtaining informed consent Assisting the doctor when necessary Daily financial oversight: Electronic claim submissions, accounts payable, accounts receivable, and bank deposits Verifying insurance eligibility and statement submission to support coverage Coordinating the scheduling of treatment for patients Obtaining prescriptions and sending it to the appropriate pharmacy Providing patients with pre/post medical care, ensuring that patients have taken necessary medication for treatment Assuring charts were properly documented Coordinating staff meetings In charge of maintaining employees’ medical certifications, current licenses and provided regulatory agencies with required information Verified and maintained log for supplies, medications and product inventory, as well as, expiration dates Making impressions, temporary crowns, and coronal polish Taking X-rays Obtaining vital signs Logging prescription inventory, calling in prescriptions Journalizing clinical entries and verifying against source documents