Meredith Auerbach Email & Phone Number

 Ensure compliance with FDA regulations and ICH guidelines by meticulously managing the regulatory aspects of clinical study binders throughout the study lifecycle. Oversee the preparation and submission of regulatory documents to IRBs and CROs, facilitating timely approvals and adherence to regulatory timelines. Act as a liaison between Principal Investigators, Sub-Investigators, and Study Coordinators, fostering effective communication to address regulatory requirements across multiple studies. Track and manage regulatory submissions and approvals, ensuring all documentation is complete and accurately filed in compliance with established SOPs and guidelines. Collaborate with CROs, sponsors, and external vendors to ensure seamless document completion and filing from study award to closeout.  Prepare comprehensive site documents and e-binders for monitoring visits, working closely with research teams to resolve any compliance issues promptly. Support HR in onboarding new staff, ensuring the collection and maintenance of required training documentation and certifications. Monitor staff credentials and maintain up-to-date CVs, ensuring compliance with regulatory standards.

Education & Early Childhood Program Manager Managing program activities and events and providing support to the Director of Education and 15 teachers in this private school with up to 150 students, pre-K through high school. Planning, organizing and coordinating all phases of the education and early childhood education program: Scheduling classes and managing registration. Serving as liaison between administration and families and providing support to families as needed. Administering program budget, generating reports and maintaining accounting records. Organizing, making all arrangement and coordinating events, including trips for up to 30 students and staff to Los Angeles, Philadelphia and Washington DC.

Bellevue, Wa

Managed individual and group reservations for hotel chain with 8 locations. Serving as liaison between Group Sales and VIP/Corporate Clients. Responded to guest inquiries and concerns, quickly resolved any issues or problems and ensured a positive customer experience for guests across all 8 properties. Provided training for new team members on Standard Operating Procedures.

Lake Buena Vista, Fl

Managed a 50-member field team and reservations for this third-party affiliate of Disney that provides in room childcare services for guests visiting Disney World. Developed positive, trusting working relationships with customers while managing the reservation process and responding to special guest requests. Ensured smooth and efficient flow of operations to maximize return on investment. Scheduled, coordinated and supervised 50 childcare providers to meet customer requests, respond to their changing needs and optimize weekly schedules. Prepared and tracked employee payroll. Improved customer satisfaction by responding to all customer inquiries with a personal message.

Bethesda, Md

• Collaborated with teachers to deliver lesson plans to provide a consistent classroom experience for students.• Organized and managed equipment and students for physical education program.• Assessed student skills and adapted lesson plans to meet their educational needs.• Worked to develop students with a variety of mental and physical disabilities.

Lake Buena, Florida

Youth Activities Counselor/Staff Trainer, Disney Cruise Line | Bahamas (2012-2013)Supported and coordinated operational needs for 40 counselors responsible for supervising 200+ children aboard cruise ships, including responsibility for schedules, breaks and last-minute schedule changes.  Increased participation in activities and guest satisfaction by creating engaging programs and activities. Improved safety and security of children by providing training on new operating system for 80+ crewmembers. Oversaw shadowing program for counselors and managers to provide opportunities to learn the importance of adhering to Disney Quality Standards. Mentored new crew members to ensure successful onboarding and ease transition to the team.

Washington D.C. Metro Area

• Managed schedule for Athletic Director and Associate Athletic Director.• Worked with University officials to support athletic programs across 14 sports.• Supported coaches and student athletes to ensure their needs were met by the Athletic Director. • Communicated with donors to encourage donations to the athletic program.• Audited ticket sales for two basketball teams for review by NCAA auditors.

• Managed payments and seating for season ticket holders.• Collected, distributed, and coordinated ticket payments between TicketMaster and the University’s finance office. • Supervised ten student workers during games throughout three NCAA seasons. • Organized special events such as parent’s weekend and basketball tournaments.

Education record

Education record