Monique Minzel

Monique Minzel USA-Austin-5707-Southwest-Pkwy Project Specialist Biography Monique Minzel has1 year of experience in the Contract Research Organization (CRO) Industry as a Project Associate in Phases 1 - IV studies and 3 months experience as a Quality Assurance Specialist. These experiences have culminated in Monique Minzel being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life. Professional Experience Nov 2019 - Present Syneos Health Project Specialist - Set-up, maintain and/or close out project files and study information (e.g., regulatory documents, Trail Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. - Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). - Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. - Provide administrative support to Project Leads and functional leads. - Ensure all study documents are archived based on the appropriate guidelines and policy. - Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues. Jan 2019 - Nov 2019 Trial Runners/ Dickinson ND Project Associate - Engaged with clinical operations, business operations, and clinical development on a day to day basis for assigned duties and tasks. - Worked closely with the project manager for timely delivery of recurrent tasks; provided consistently with a high degree of accuracy. - Managed and reported on site selection process and status by developing and distributing feasibility questionnaires and CDAs. Collate collected information into graphs and charts as needed and provided status presentation on a weekly basis. - Managed the development and distribution of various forms/templates including the Informed Last Updated: 21-NOV-2019 © 2018 All rights reserved | Confidential | For Syneos Health use only Page 1 of 5 Consent Form template, study site budgets, CRFs, template source documents, training manuals, regulatory and procedure manuals and any other site-specific forms or resource materials. - Managed and maintained internal study specific trackers. - Managed vendors such as IRBs, reading centers, etc. (e.g. central/local IRB). - Presented at project meetings (internal or external). - Coordinated project meetings and produced meeting minutes. - Interacted with the Sponsor, study sites, and internal associates. - Managed logistics of study set-up activities including obtaining CDAs, MSAs, and training records of all personnel. - Managed and oversaw marketing feasibility reporting. Nov 2018 - Jan 2019 Trial Runners/ Dickinson ND Quality Assurance Specialist - Promoted the culture of quality throughout the organization and promoted continuous compliance and improvement of Trial Runners' Quality Systems and Quality Management Plan. - Assisted in the development and maintenance of document control. - Maintained the TMF electronic and hard copy filing systems. - Maintained checkout system for files that have been temporarily removed for record review, inspections, audits, investigations, etc. Ensured all records are returned and intact at the end of the business day. - Labeled, organized, and stored files in a manner that made them readily accessible for auditors and for authorized staff use. - Ensured all TMFs remain confidential and follow HIPAA policies and procedures, protecting records from breaches of confidentiality and/or unauthorized use. - Completed data entry from Document Dispatch Forms (DDFs) and other assignments while meeting quality standards for accuracy, neatness, and thoroughness. Ensured the organization, cleanliness and professionalism of the CDC area. - Served as primary point of contact for Trial Runners' electronic quality system, which included input, tracking, and utilization of all company training records, training matrixes, vendors & contactors, CAPA's, and SOP's. - Conducted employee training to encourage users to be successful in the electronic quality system. - Ensured all employees' individual training was in accordance with the position specific defined training matrix. - Analyzed, evaluated, and presented improvement opportunities and/or compliance concerns associated with the quality systems (focused on SOPs, Deviations and CAPA systems), escalated any identified risks to management. - Provided new employee orientation training to all incoming staff to include overview of QA and company QMS, training matrix assignments and required SOPs, and CV assignment and collection. Last Updated: 21-NOV-2019 © 2018 All rights reserved | Confidential | For Syneos Health use only Page 2 of 5 - Assisted QA team in auditing programs, specifically TMF audits and assisted in gathering missing documentation and/or correction of DDF document. - Participated in company required training programs. - Maintained open communication with direct supervisor regarding any comments, concerns and/or issues. - Performed other duties as assigned. Jan 2018 - Nov 2018 Bank of the West/ Dickinson ND Service Banker - Processed customer transactions accurately of all deposits, transfers, withdrawals, and other transactions in accordance to bank policies, procedures and regulatory requirements. - Identified sales and cross selling opportunities and made qualified referrals to specialist sales partners. - Performed outbound calls for service/ sales follow up in support of MCCRM goals. Jul 2017 - Present United States Army National Guard Private E1/ Combat Engineer - Look out for areas that are suitable for the construction of combat structure. - Design and erect structures like rails, roads, hammocks, temporary bridges or prefabricated bridges, firing points and shelters to store weapons. - Place mines and other explosives. - Help the troop in movement by overseeing loading and unloading of military equipment and arranging their placement in the vehicles. - Detection of explosives like landmines placed by enemies and disposing them. - After the construction work is done, join the troops for the real combat. Dec 2016 - May 2017 GE Oil and Gas/ Dickinson ND Administrative Assistant - Proactively supported internal customer by independently handling all assigned administrative duties and taking direction from and balancing the needs of multiple staff members. - Provided administrative support to clients through effectively maintaining and coordinating calendars, scheduling appointments and meetings, making travel arrangements, telephone coverage (if needed), filing, processing and reconciling expense accounts, handling various purchases and making AP invoice arrangements. - Scheduled, planned and organized all logistical details for in-house and off-site meetings, training and events. - Developed PowerPoint presentations and other graphic presentations; typed various correspondences both in own signature and in manager's signature. - Provided general office administrative services. - Supported budget management, liaised with finance to ensure costs are monitored and controlled. Last Updated: 21-NOV-2019 © 2018 All rights reserved | Confidential | For Syneos Health use only Page 3 of 5 - Assisted with job candidate interview scheduling. - Entered temporary support requests into My Resources or other generating system. - Ran reports in Excel, Access, Business Objects and other data gathering programs. - Input and updated data into Oracle databases. - Provided tactical support (answered questions on central sites and on various internal processes and e-tools). - Helped keep organization charts up to date as directed. - Maintained filing and records management systems and other office flow procedures which may have been confidential. - Provided payroll support for hourly associates. - Generated, reviewed and filed pharmacy reports. - Accurately maintained customer pricing files and completed contract data entry. - Created statistics, sent out customer brochures or correspondence, or document leads. Nov 2008 - Jan 2015 Amazon LLC/ Manila Philippines Supervisor/ Team Leader - Handled a team of Customer Service Representatives and was responsible for each one's professional and personal growth with the Company. - Monitored account's Service Level on an interval basis. - Monitored agent performance and filled out feedback form for serving. - Stayed calibrated with Amazon, peers and the Quality Coaches. - Monitored calls and scheduled adherence. - Coached each agent on team at least once per week and updated their Agent Personalized Development Plan. - Completed a Semi-Annual Performance Assessment for each agent on the team. - Took Supervisor Escalations when required. - Promoted Amazon products (Kindle) to hit a target sales goal. - Planned, organized, coordinated, promoted, and facilitated special events and campaigns including Employee Recognition Program in all efforts to maintain employee's morale at a high level. - Oversaw Customer Call Back and Follow-ups as required. - Approved concessions beyond the agent's limit. - Answered questions/provided support to agents on a consultation basis. - Answered customer inquiries when needed due to volume. Therapeutic Experience Oncology - Cancer, Multiple Myeloma Ophthalmology - Dry Eye Glaucoma Last Updated: 21-NOV-2019 © 2018 All rights reserved | Confidential | For Syneos Health use only Page 4 of 5 Ophthalmology - Glaucoma, Open Angle Macular Degeneration, Age-Related Ocular Hypertension Languages English - Speaking, Reading, Writing Tagalog (Philippines) - Speaking, Reading, Writing - Native Additional Experience - Electronic TMF review GCP Auditing Paper CRF Quality Assurance TrialMaster EDC Education 2011 STI College - Philippines Bachelor - Business Administration Last Updated: 21-NOV-2019 © 2018 All rights reserved | Confidential | For Syneos Health use only Page 5 of 5