Cortney Barna
Somerville,United States
Summary
Seasoned Clinical Research Site Director with a proven track record at Princeton Consumer Research, adept in operational leadership and facility management. Excelled in enhancing enrollment goals and ensuring regulatory compliance, while fostering a team-oriented environment. Skilled in protocol review and quality assurance, demonstrating a commitment to excellence in Clinical research.
Overview
6
6
years of professional experience
Work History
Clinical Research Site Director
Princeton Consumer Research
10.2023 - 11.2024
- Responsible for the overall site conduct under the direction of the Regional Directors. Ensuring delivery of enrollment goals while maintaining adherence to any regulations, ICH guidelines and the SOPs in all aspects of conducting clinical trials. The Site Director is able to function and still partakes in all levels of a Clinical Research Coordinator.
- Supports Sponsors during Site Visits
- Manages the most challenging therapeutic areas and study designs
- Able to monitor and mentor all levels of the team to ensure complete understanding of the protocol processes, SOPs, and values to complete the clinical trials
- Ensures HR policies are implemented and maintained
- Work with site staff in training and documentation practices
- Fostered a team-oriented environment at all times
- Keep Regional Manager appraised of any study related costs and any changes that may affect the performance of the site revenue.
- Keeping monthly logs of study revenues and expenses
- All bank deposits and withdrawals for study expenses and subjects fees
- Review and assess protocol for clarity, logistical feasibility, safety, and any inconsistencies
- Assist PI and the study supervisor to ensure all training and study requirements are met prior to trial conduct
- Maintain study test products, the required procedures, eligibility criteria and impact of office flow with staff and PI
- Coordinate and attend all pre study meetings, Sponsor visits, SIVs, monitor visits and audits
- Determine facility, equipment and outsource vendor requirements and availability
- Coordinate and arrange scheduling with physicians needed to assist on studies
Clinical Research Principal Investigator
Princeton Consumer Research
09.2023 - 11.2024
- Followed informed consent processes and maintained records.
- Assessed potential risks associated with projects, implementing mitigating strategies to ensure the safety of all team members and study participants.
- Coordinated multi-site studies to address large-scale questions, leveraging diverse expertise across institutions for optimal outcomes.
- Documented findings and prepared detailed reports.
- Collected, analyzed and interpreted information, documentation, associated with clinical trials.
- Gathered, processed, and shipped lab specimens.
- Worked with SUB PI and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed sensitive case information with utmost discretion, ensuring confidentiality and integrity in all proceedings.
- Overseen the safety and study procedures for subjects/ study participants on assigned studies.
- Overseen study staff regarding study execution and interacts with sponsors on protocols and study reports.
Clinical Research Coordinator
Eurofins
09.2018 - 08.2020
- Responsible for the overall site conduct under the direction of the Regional Directors. Ensuring delivery of enrollment goals while maintaining adherence to any regulations, ICH guidelines and the SOPs in all aspects of conducting clinical trials. The Site Director is able to function and still partakes in all levels of a Clinical Research Coordinator.
- Supports Sponsors during Site Visits
- Manages the most challenging therapeutic areas and study designs
- Able to monitor and mentor all levels of the team to ensure complete understanding of the protocol processes, SOPs, and values to complete the clinical trials
- Ensures HR policies are implemented and maintained
- Work with site staff in training and documentation practices
- Fostered a team-oriented environment at all times
- Keep Regional Manager appraised of any study related costs and any changes that may affect the performance of the site revenue.
- Keeping monthly logs of study revenues and expenses
- All bank deposits and withdrawals for study expenses and subjects fees
- Review and assess protocol for clarity, logistical feasibility, safety, and any inconsistencies
- Assist PI and the study supervisor to ensure all training and study requirements are met prior to trial conduct
- Maintain study test products, the required procedures, eligibility criteria and impact of office flow with staff and PI
- Coordinate and attend all pre study meetings, Sponsor visits, SIVs, monitor visits and audits
- Determine facility, equipment and outsource vendor requirements and availability
- Coordinate and arrange scheduling with physicians needed to assist on studies
Clinical Research Coordinator
Princeton Consumer Research
08.2020 - 11.2023
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
Education
Pharmacy Technician - Pharmacy
Everest Institute
South Plainfield, NJ01.2011
Licensed Esthetician - Esthetics
East Brunswick Vocational School
East Brunswick, NJ06.2005
High School Diploma -
Piscataway High School
Piscataway, NJ06.2001
Skills
- Operational leadership
- Operational planning
- Operations management
- Facility management
- Corneometer efficiency
- Subumeter efficiency
- Cutometer efficiency
- TEWL efficiency
- Visia CR/ Visia with Primos efficiency
- NACDG grading scale
- Clinical skin grading
- Anti- aging grading
- Assisted Gynecologists/ Dermatologists/ Ophthalmologists
- Protocol review and signing of the final report
- ICH/ GCP completed training
- Biomedical research completed training
- GCP US FDA focus training completed
- Staff management
- Team supervision
- Quality assurance
Timeline
Clinical Research Site Director
Princeton Consumer Research
10.2023 - 11.2024
Clinical Research Principal Investigator
Princeton Consumer Research
09.2023 - 11.2024
Clinical Research Coordinator
Princeton Consumer Research
08.2020 - 11.2023
Clinical Research Coordinator
Eurofins
09.2018 - 08.2020
Pharmacy Technician - Pharmacy
Everest Institute
Licensed Esthetician - Esthetics
East Brunswick Vocational School
High School Diploma -
Piscataway High School
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