Anna Young
Winthrop Harbor
Summary
Results-driven professional with strong background in project closeout processes and compliance management. Known for efficiently finalizing projects by collaborating with diverse teams and resolving any outstanding issues. Reliable team player dedicated to achieving results and adapting to changing project needs, while displaying exceptional organizational and communication skills
Overview
9
9
years of professional experience
Work History
Clinical Trial Material Inventory Closeout Specialist
Astellas Pharma (Contractor with Randstad Pharma)
12.2018 - Current
- Provide clinical supply support for specific clinical supply operational tasks in accordance with client procedures and processes including the following:
- Reconciliation to destruction workflow
- Monthly Sunshine Act reporting
- Filing of documentation in appropriate repository and support of other CTM Operations team members and assigned activities
- Assisted in updating Destruction and Reconciliation Process SOPs
- ~7 years of advanced Microsoft Excel knowledge including SUMIF, COUNTIF and VLOOKUP functions
- CTM Label creation training
- US Only Labels
- Updating LSFs
- Using Depot Gateway system to approve label creation
Clinical Trial Associate-Site Manager
GlobalCare Clinical Trials
07.2018 - 11.2018
- Manage 80 patients’ visit scheduling
- Manage 50+ nurses’ visit scheduling, training, and documentation
- Manage roughly 600 source documents monthly from beginning to end of the process
- Retrieve from nurse and enter information into study tracker
- Quality Check and request corrections
- Save in files and submit to medical sites
- Train new employees on processes
- Supervise activities
- Recruit nurses to cover patients’ visits across the United States
- Organize study trackers in Excel for three different studies
- Collaborate with team members on solving problems and making changes to source documentation and training manuals
- Coordinated clinical trial activities to ensure compliance with regulatory guidelines and protocols.
- Managed documentation for multiple clinical studies, enhancing accuracy and accessibility of trial data.
- Collaborated with cross-functional teams to streamline processes and improve overall study efficiency.
- Trained junior staff on clinical trial procedures, fostering knowledge sharing and team development.
- Streamlined clinical trial processes by implementing efficient data management systems and documentation practices.
- Implemented comprehensive quality control measures to ensure accurate data collection and reporting across all aspects of the study.
- Provided critical support during audits or inspections by promptly addressing any concerns raised by regulators or sponsors regarding trial conduct or documentation practices.
- Developed strong relationships with site personnel, fostering a collaborative environment conducive to successful trial execution.
- Ensured compliance with regulatory guidelines, maintaining accurate and up-to-date records throughout all phases of the trial.
Clinical Trial Assistant
GlobalCare Clinical Trials
06.2017 - 07.2018
- Coordinated clinical trial documentation and maintained regulatory compliance across multiple studies.
- Assisted in scheduling patient visits and managing participant recruitment strategies effectively.
- Facilitated communication between cross-functional teams to ensure timely project updates and information sharing.
- Maintained accurate tracking of clinical trial supplies, ensuring availability for uninterrupted study activities.
Administrative Assistant
GlobalCare Clinical Trials
10.2016 - 06.2017
- Coordinated scheduling and logistics for clinical trial meetings and participant engagements.
- Developed and maintained filing systems to enhance document retrieval efficiency.
- Monitored inventory levels of office supplies, initiating restock orders as needed.
- Facilitated onboarding processes for new team members, promoting a collaborative work environment.
- Answered multi-line phone system, routing calls, and delivering messages to staff.
- Maintained confidentiality of sensitive information by adhering to strict privacy policies and implementing secure filing systems.
- Delivered excellent customer service through prompt responses to client inquiries, addressing concerns effectively, and building strong relationships.
- Ensured accurate record-keeping with diligent data entry and database management for vital company information.
- Promoted a positive work environment through effective communication skills and fostering professional relationships among colleagues.
Education
Masters of Public Health - Emphasis in Management of Health Services
Northern Illinois University
DeKalb, IL05.2016
Bachelor in Arts - Psychology and Sociology Double Major
Northern Illinois University
DeKalb, IL05.2013
Skills
- Alzheimer’s and Dementia training; 4-5 years of experience with elderly and dementia population
- Intermediate Excel Training, Microsoft Word, PowerPoint
- Training for the shipping of Category A, infectious Substance Affecting Humans, and Category B, Biological Substances
- Completion of certificate from NIH regarding “Protecting Human Research Participants”
- List of other trainings available upon request (Trainings are assigned regularly to keep me up to date with my education These include, but are not limited to, various SOP trainings, Temperature Excursion trainings and Label Creation trainings)
- Documentation review
- Dispute resolution
- Relationships and rapport
- Telephone etiquette
- Confidential records
- Document control
- Requests for information
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Achieved [Result] through effectively helping with [Task].
- Documented and resolved [Issue] which led to [Results].
- Achieved [Result] by completing [Task] with accuracy and efficiency.
Languages
English
Native or Bilingual
Spanish
Elementary
Timeline
Clinical Trial Material Inventory Closeout Specialist
Astellas Pharma (Contractor with Randstad Pharma)
12.2018 - Current
Clinical Trial Associate-Site Manager
GlobalCare Clinical Trials
07.2018 - 11.2018
Clinical Trial Assistant
GlobalCare Clinical Trials
06.2017 - 07.2018
Administrative Assistant
GlobalCare Clinical Trials
10.2016 - 06.2017
Masters of Public Health - Emphasis in Management of Health Services
Northern Illinois University
Bachelor in Arts - Psychology and Sociology Double Major
Northern Illinois University