Kerri Berlin
Carlsbad
Summary
Clinical program management healthcare professional with comprehensive background in overseeing clinical trials and research initiatives. Recognized for driving successful program outcomes through effective leadership and strategic planning. Known for strong team collaboration and achieving results, adaptable to evolving requirements, and proficient in regulatory compliance and stakeholder communication.
Overview
19
19
years of professional experience
Work History
Clinical Program Manager II
ENOVIS
04.2023 - 10.2024
- Design and draft clinical trial and usability validation protocols to cultivate clinical evidence to support research and development claims and project feasibility
- Assist in managing the Clinical Affairs budget, contract negotiation, administration, and department financial tracking and reporting
- Review and approve marketing literature, FMEAs, or other regulatory documents
- Provide clinical updates to cross-functional team members at routine and ad-hoc meetings
- Oversee the maintenance of study-related platforms such as the eTMF, EDC, CDMS, etc
- Key liaison between CROs/Vendors/3rd parties specific to their projects/studies and assists with vetting, obtaining contracts, and invoicing issue resolution
Clinical Program Manager
BECTON DICKINSON
01.2020 - 05.2022
- Responsible for operational aspects, including multi-site monitoring and interdisciplinary collaboration to support multiple, complex research initiatives per applicable regulatory requirements (GCP and SOPs)
- Collaboratively created and designed clinical trial protocols, case report forms, and other pertinent study documentation
- Track, evaluate, and report study progress/metrics through cross-functional project analysis by evaluating timeline/milestone updates and any communicated issue identification resolution
- Perform routine investigative site file reconciliation to ensure data source and documentation integrity and confirm the resolution of any outstanding data query initiation
- Communicate with necessary regulatory bodies to maintain study eligibility by preparing submissions and reporting protocol amendments AEs/protocol deviations
Clinical Research Coordinator (Contractor)
BECTON-DICKINSON
12.2019 - 04.2021
- Responsible for the regional launch of a multi-site biospecimen collection program to support various R&D initiatives (ultimately promoted/hired to above CPM position)
- Manage and organize operational workflow according to protocols of ICH-GCP and regulatory requirements, including donor recruitment strategies, informed consent, donor event scheduling, performing biospecimen collection and storage using safe laboratory practices
- Train, delegate, and evaluate study-related roles, responsibilities, and milestones for core team members expedited trials launch
- Initiate and establish CTMS and EDC tools to streamline and enhance data capture, reporting, and procedural analysis
Clinical Program Director
RED BOX PROJECT
02.2018 - 02.2021
- Development and oversight & management of public health education & policy programs within the non-profit sector
- Investigational Field research, survey campaigns & data analytics to provide empirical data for promotional health initiatives & product development
- Participant training, site initiation visits, program monitoring, grant writing, evaluation reports & cost budget analysis
- Design educational & promotional-related press materials to engage and recruit vendor/stakeholder, institutional & community support
Public Health Nurse (seasonal role)
MAXIM HEALTHCARE
08.2019 - 03.2020
- Assessment of individual health status; provide relevant health education and referrals
- Collaborate and communicate with healthcare teams and community organizations
- Implement infection control and environmental safety policies and procedures
Community Health Specialist
Nurse Managed Clinic
06.2018 - 07.2019
- Designed, implemented, and evaluated public health program
- Ethical and regulatory oversight, responsible conduct of research administration
- Created grant proposals, executive summaries, and cost-benefit analyses
Nurse Supervisor
KAISER PERMANENTE
08.2009 - 05.2014
- Back-office nurse supervisor; code response team lead and referral liaison
- Internal medicine, Oncology, OBGYN & chronic disease management
- Assist in independent research initiatives to support drug, device, and interventional development
Health Examiner
EMSI Health Services, Inc.
01.2006 - 01.2014
- Complete physical and forensic examination of applicants for clinical trials, and various wellness programs
- Data collection and analysis
- Biomedical Sample collection and transport/Laboratory services
Clinical Nurse
SHARP REES STEELY
01.2007 - 08.2009
- Project management and clinical trial coordination
- Population-based medicine management
- Direct patient care, health education, and administrative tasks
Education
Associates Degree - Nursing
Kaplan College
Vista, CA05.2007
Master Of Public Health - Clinical Research
National University
La Jolla, CA05.2019
Bachelor Of Science - Public Health
National University
La Jolla, CA05.2016
Skills
- Clinical trial management
- Multi therapeutic area expertise
- Protocol development
- Direct Patient care
- Effective communication
- Clinical documentation
- Strategic planning
- Regulatory compliance
- Recruitment and retention
- Quality assurance process optimization
Timeline
Clinical Program Manager II
ENOVIS
04.2023 - 10.2024
Clinical Program Manager
BECTON DICKINSON
01.2020 - 05.2022
Clinical Research Coordinator (Contractor)
BECTON-DICKINSON
12.2019 - 04.2021
Public Health Nurse (seasonal role)
MAXIM HEALTHCARE
08.2019 - 03.2020
Community Health Specialist
Nurse Managed Clinic
06.2018 - 07.2019
Clinical Program Director
RED BOX PROJECT
02.2018 - 02.2021
Nurse Supervisor
KAISER PERMANENTE
08.2009 - 05.2014
Clinical Nurse
SHARP REES STEELY
01.2007 - 08.2009
Health Examiner
EMSI Health Services, Inc.
01.2006 - 01.2014
Associates Degree - Nursing
Kaplan College
Master Of Public Health - Clinical Research
National University
Bachelor Of Science - Public Health
National University
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