- Roche Diagnostic Solutions’ first Boston, Massachusetts Clinical Research Associate- Performed site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice.- Supported development of project subject recruitment plans on a per site basis, while working with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. - Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas. - Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluated the quality and integrity of study sites practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalated quality issues as appropriate.- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. - Created and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.- Built awareness of features and opportunities of study to site.- Collaborated and liaised with study team members for project execution support.

- Conducted site initiation visits for the onboarding of new collection sites and new project start-ups for existing sites, as well as site close-out visits.- Successfully conducted interim onsite and remote monitoring for high-enrolling clinical sites, monitoring a wide array of adult and pediatric in-vitro diagnostic studies by either risk-based monitoring or 100% monitoring.- Managed 8+ contract CRAs remotely by coaching them on sponsor specific protocols, monitoring requirements, Client specific requirements, approving hours, reviewing and approving reports, and setting metric standards.- Analyze client and sponsor specific project scopes to accurately prepare monitoring plans for in-vitro diagnostic and med device studies.- Completed data queries for monitoring purposes to external sites for completion and correction of clinical data.- Reviewed and approved CRFs for completion and accurate information prior to data entry.- Solely managed and organized hardcopy and eTMF regulatory files for over 84 outside clinical and diagnostic sites, both existing and newly recruited, as well as 10 protocols.- Produced a universally utilized Regulatory Compliance Summary tracker for all essential documents required in a Trial Master File for all sites.- Assisted in the project deliverables for COVID-19 Biospecimen collection projects nationwide.- Managed IRB Submissions for both site level and sponsor level submissions, maintenance and correspondence. - Coordinated kit supply fulfillment from request to delivery for 11 projects and 40 clinical sites simultaneously on a daily basis.- Analyzed and composed risk assessments for various clinical research Biospecimen procurement projects.- Assisted the clinical department with in-house Biospecimen collection tasks, such as COVID-19 swabbing, obtaining informed consent, completing and querying of case report forms.

- Effectively managed over 10+ simultaneous international product registrations consistently for tissue and medical devices, increasing company revenue by over $1 million.- Oversaw regulatory requirements for new projects pertaining to domestic and international private label contracts.- Controlled 90 company license renewals, over 35 division five vendor licenses, state and federal ARCOS reporting, and maintenance of over 500 controlled substance purchasing customer license files.- Independently took lead on all domestic and international regulatory affairs as a single-employee team while maintaining responsibilities as a quality assurance associate and internal auditor, effectively eliminating the need for additional resources.- Solitarily inspected all product quality complaints and failed implants for defects and imperfections.- Assisted in the compiling of responses, evidence, and corrective actions for major findings in external audits.

- Maintained a number one ranking amongst highly experienced customer experience representatives.- Learned a complex clinical product offering of over 18,000 SKU’s to become the in-house representative for clinical and technical support for customers.- Increased standard number of calls taken on a monthly average while decreasing talk time per phone call, while maintaining a high level of customer satisfaction.- Generated upwards of an additional $10k a month in upsells based on monthly promotions.

Gave informational tours of the historical Lizzie Borden house to groups of guests ranging from 2-40, as well as over-night hosting.