Karla Gonzalez
Indianapolis,IN
Summary
Clinical Project Manager well-versed in study protocols, standard operating procedures, and general clinical research oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 9 years of related experience to a challenging new role.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Clinical Project Manager
Azenta Life Sciences
Indianapolis, IN
11.2022 - Current
- Manage complex portfolio of up to 30 clients, expanding across clinical trial samples and pharmaceutical drugs (GMP and non-GMP) ensuring project goals and deliverables are met across all
- Improved KPIs for key metrics for affected clients
- Resolved long-standing issues for inherited projects, consequently setting up clients for success
- Collaborated on several quality agreements and SOPs for improved processes
Clinical Research Coordinator
Indiana University School of Medicine
Indianapolis, IN
01.2020 - 11.2022
- Managed team tasks and priorities while maintaining bio specimen and clinical data and documentation for over 14 studies.
- Performed reconciliation of study data for study sites and bio repository lab data, extracting reports from LIMS and EDC
- Helped create and edit CRFs for multi-site studies
- Prepared data cleaning and reports for metrics, inventory, and reconciliation reports
- Helped prepare budgets for incoming closed studies, and start-up studies
- Initiated and oversaw over one hundred bio specimen requests for external investigators and companies
- Trained subordinates and quality checked their work, while simultaneously maintaining own duties
- Primary point of contact for study sponsor, bio repository lab and sister bio repository labs in Israel and Italy
- Responsible for submissions to IRB and ensuring study compliance
- Recognized for scientific presentations and manuscripts.
Clinical Research Specialist
Indiana University School of Medicine
Indianapolis, IN
08.2017 - 01.2020
- Managed over 1,000 incoming CRFs for incoming bio specimens.
- Selected for committee to help establish standardization and effective workflows between lab and project management
- Managed Parkinson's research sub study from start-up and data management throughout its duration
- Corresponded with clinical sites and clinical trial coordination center for protocol deviations, missing data, discrepancies, and data query follow-up
- Main point of contact for training and bio specimen issue resolution.
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Designed, constructed and implemented research proposals, protocols and procedures
Specimen Management Team Lead
Covance Laboratories
Indianapolis, IN
02.2015 - 08.2017
- Trained fully for 2 departments, 5 different teams within first year resulting in multifaceted knowledge
- Lead creative process improvements across departments
- Ranked in Top 10% with Exceeds Expectations for first end of year evaluation
- Ranked Far Exceeds at end of year 2016 for department by providing pivotal role within department teams when facing high turn-over
- Increased productivity of 66% after taking over as team lead
- Engaged team members by assigning tasks that suit their strengths and provided training to new hires.
Laboratory Research Assistant
Indiana University
Bloomington, IN
05.2010 - 05.2011
- Headed two projects consisting of building own cell lines in yeast to then present findings on genetic mutations
- Developed understanding of scientific writing and process to accurately reflect work
- Conducted research, gathered information from multiple sources and presented results
- Formed relationships with team members of varying ethnic and education backgrounds which helped in communication and better working environment
Education
B.S - Biotechnology
Indiana University Bloomington
Bloomington, IN05.2013
Skills
- Good Clinical Practice
- Study Protocols
- Complex Problem-Solving
- Creative Thinking
- Client Support
- Specimen Coordination
- Microsoft Excel
- Data Management
- Project Management
- Cross-functional Leadership
- Critical thinking
- Problem solving
- Effective communication
- Training and mentoring
Certification
Clinical Research, SOCRA, 2019
Accomplishments
- IMSD Scholar, 2010-2013
- Hudson and Holland Scholar, 2008-2013
- IU Recognition Scholarship, 2008-2013
- Selected as team lead to LA LabCorp site to organize inventory move of over 10,000 specimens
- 15 Time ACE Award Recipient in areas of Process Excellence and Client Experience followed by People Excellence, 2015-2016
Personal Information
Title: CCRP
Therapeutic Areas
- Parkinson's Disease
- Alzheimer's
Timeline
Clinical Project Manager
Azenta Life Sciences
11.2022 - Current
Clinical Research Coordinator
Indiana University School of Medicine
01.2020 - 11.2022
Clinical Research Specialist
Indiana University School of Medicine
08.2017 - 01.2020
Specimen Management Team Lead
Covance Laboratories
02.2015 - 08.2017
Laboratory Research Assistant
Indiana University
05.2010 - 05.2011
B.S - Biotechnology
Indiana University Bloomington