Krista Baer
Summary
Bachelor's in nutrition and food sciences and Master's in Public Health 12 years of experience in Clinical Research and data quality and integrity Managed and oversaw clinical study sites for pivotal drug, medical device, and vaccine development trials across Phases I-IV Providing comprehensive leadership in clinical operations and project management oversite, with a dedicated focus on study deliverables such as risk mitigation, ICH-GCP and FDA compliance, participant enrollment, and precise data collection Ensuring accuracy and thoroughness in all aspects of clinical research from study start up to study completion Maintains complete and accurate regulatory documents such as ICF, DOA logs, training logs, and various other important regulatory documents Results-driven research professional prepared for challenges of overseeing clinical studies. Proven track record of managing complex projects and ensuring compliance with research protocols. Known for fostering team collaboration and adapting to evolving project needs, while excelling in data management and regulatory adherence.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator
Velocity Clinical Research
06.2023 - Current
- Maintained high standards of data integrity by implementing rigorous data collection and documentation, contributing to the accuracy and reliability of study results
- Successfully recruited, screened, and enrolled eligible participants across diverse trials, consistently achieving and sustain an exceptional participant retention rate of 95%
- Guided the preparation and submission of more than 10 IRB amendments and continuing reviews, ensuring the timely approval of research studies while upholding complete compliance with institutional and regulatory mandates
- Exemplified unwavering dedication to ethical research practices by prioritizing participant safety, privacy, and informed consent at every stage of the trial
- Orchestrated the seamless coordination and execution of numerous Phase II and III clinical trials in liver diseases (NASH, bile duct diseases, drug induced liver injury), ensuring compliance with FDA regulations and ICH-GCP guidelines
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
- Increased patient retention rates by establishing strong relationships with participants through effective communication and followup.
- Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Site Development Manager
Care Access
07.2021 - 04.2023
- Orchestrated clinical research site selection, set up, and maintenance securing a 70% success rate in a manager that aligns with regulatory standards and organizational goals
- Led the strategic expansion of clinical research sites, resulting in an 25% increase in number of operational research sites within a five-month period
- Cultivated and maintain strong relationships with key stakeholders, resulting in successful enhancement of the organization's overall research capacity and competitiveness in the clinical research space
- Leveraged strong analytical and problem-solving skills to identify and evaluate potential research sites, considering factors such as patient demographics, investigator expertise, and infrastructure
- Orchestrated the seamless coordination and execution of numerous Phase II and III clinical trials in infectious diseases (COVID-19, influenza A, B) ensuring compliance with FDA regulations and ICH-GCP guidelines
- Presented project updates during executive meetings to maintain transparency around progress towards key objectives while addressing any concerns raised by leadership stakeholders.
- Balanced competing priorities and resource constraints to deliver optimal results within the context of project timelines and budgetary restrictions.
- Improved overall project efficiency by setting clear goals, milestones, and expectations for the development team.
- Negotiated contracts with vendors and service providers for cost-effective solutions that supported project requirements.
- Established effective communication among team members for enhanced collaboration and successful project completion.
Clinical Research Coordinator
Rainier Clinical Research Center
03.2019 - 07.2021
- Committed in advancing diabetes research, ensuring patient well-being, and contributing to the overall success of clinical trials within a diabetes clinic
- Successfully enrolled and retained a diverse cohort of participant for clinical trials, exceeding recruitment targets by 10% and maintaining a participant retention rate of 95%
- Collaborated seamlessly with investigators, sponsors, and various stakeholders, ensuring alignment and effective communication
- Facilitated a collaborative approach to problem-solving, resulting in improved study outcomes
- Orchestrated the seamless coordination and execution of numerous device and pharmaceutical Phase I, II and III clinical trials in endocrinology studies (diabetes, hypothyroid) ensuring compliance with FDA regulations and ICH-GCP guidelines
- Utilized strong organizational and planning skills to drive the completion of a clinical research project within specified timeframes and budgetary constraints
Clinical Trial Manager
JBR Clinical Research
08.2017 - 01.2019
- Mentored and coached 20 staff members, empowering them to excel in their roles and enhancing their skills and expertise in the field of clinical research
- Led the development, launch, and management of a new clinical research facility
- Orchestrated the procurement and availability of necessary equipment for study assessments, ensuring compliance with safety regulations
- Oversaw the compliance of the site pharmacy with FDA regulations, including proper storage and handling of investigational products, as well as maintaining accurate temperature controls
- Implemented regular training sessions to enhance employees' skills and knowledge in the protocol and research, which led to increased data quality
- Set clear, achievable goals for individuals and teams, with measurable performance metrics, which led to improving employee productivity
Medical Research Associate (Research Coordinator)
PRA Health Sciences
08.2012 - 08.2017
- Ensured strict adherence to protocol requirements, meticulously coordinating, and executing Phase I clinical trials to guarantee the safety and integrity of study participants
- Effectively spearheaded several clinical trials, with budgets exceeding $12 million, consistently surpassing defined metrics for clinical trial success
- Contributed to the design and implementation of clinical strategy, clinical plans, and study protocols, to optimize study outcomes
- Educated participants on study procedures, potential risks, and benefits, fostering a transparent and informed consent process, and promoting a participant-centric approach in Phase I clinical research
- Demonstrated expertise in drug administration and dosing procedures, ensuring precision in drug delivery while closely monitoring participants for any signs of adverse reactions
Education
Master's Degree - Public Health
West Coast University
Irvine, CABachelor of Sciences - Nutritional and Food Sciences
Utah State University
Logan, UTSkills
- Medidata Rave
- Medrio
- Veeva Vault
- CRIO
- Oracle
- Open Clinical
- Inform
- Zelta
- Advarra
- Firecrest
- Science 37
- Ramos Ng
- Data Collection
- Clinical Research Ethics
- Study monitoring
- Site initiation
- Informed consent
- Site Management
- Research experience
- Medication Dispensing
- Scheduling proficiency
- Records Maintenance
Certification
- Certified Clinical Research Coordinator, Association of Clinical Research Professionals
- Project Management Certification, Google Certification
Timeline
Senior Clinical Research Coordinator
Velocity Clinical Research
06.2023 - Current
Site Development Manager
Care Access
07.2021 - 04.2023
Clinical Research Coordinator
Rainier Clinical Research Center
03.2019 - 07.2021
Clinical Trial Manager
JBR Clinical Research
08.2017 - 01.2019
Medical Research Associate (Research Coordinator)
PRA Health Sciences
08.2012 - 08.2017
Bachelor of Sciences - Nutritional and Food Sciences
Utah State University
Master's Degree - Public Health
West Coast University
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