Rometa Kerney
Pittsburgh,PA
Summary
Regulatory professional known for high standards and results-driven approach. Proven ability to navigate complex regulatory environments and implement effective compliance strategies. Committed to fostering team collaboration and adapting to evolving regulatory requirements. Skilled in regulatory research and compliance monitoring, valued for reliability and flexibility.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional report writing and recordkeeping abilities.
Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
19
19
years of professional experience
Work History
Lead Regulatory Specialist
UPMC Hillman Cancer Center -Clinical Research Services
Pittsburgh, PA
07.2013 - Current
- Uses a variety of resources and strategies to manage protocols as demonstrated by adherence to ethical practices during the conduct of clinical trials to protect the rights and well-being of patients, the collection of quality data, and the adherence to regulations concerning the conduct of human research as well as to all CRS SOPs.
- Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral, and meeting format, adhering to appropriate timelines.
- Understands the process for compiling disease center Data Safety & Monitoring Board (DSMB) meeting agendas and recording, disseminating, and submitting the minutes from the meeting to the appropriate regulatory bodies.
- Demonstrates dedication to the professional development of others by continuously serving as a mentor or trainer to the regulatory staff; while also acting as a role model for the staff by adhering to all CRS SOPs as well as demonstrating good work ethics, time-management skills and promoting a healthy work environment.
- Not only identifies opportunities for quality improvement, but also leads and actively participates in quality improvement efforts both at the departmental and organizational levels.
- Performs within the regulatory department with minimal to no supervision, acting as an information resource to all CRS staff and customers as well as acting on behalf of the Regulatory Specialist Supervisor when necessary.
Clinical Research Associate
UPMC Hillman Cancer Center - Clinical Research Services
Pittsburgh, PA
02.2012 - 07.2013
- Assisted in verifying subject eligibility according to protocols by reviewing medical records, laboratory, and radiology or CT scan results.
- Assisted in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.
- Shared responsibility of managing the day-to-day activities for the research protocols.
- Processed required documents as need for the research protocols.
- Developed correlative processes for Breast and Gynecological program research studies.
- Insured that patient’s records, slides, radiology tests, lab work results, etc. are obtained and reviewed prior to patient entry into a study.
- Performed consenting process and study implementation of lab, registry, and non-therapeutic clinical trials.
- Created study specific source documents, case report forms and study visit checklists.
- Assisted in entering subject trial registration and study status updates into CTMA.
Research Assistant-Basic Science
Magee-Womens Research Institute of UPMC
Pittsburgh, PA
09.2007 - 02.2012
- Performed approved research projects according to defined protocols and procedures including appropriate collection, recording, storage, and analysis of data, and reporting of results.
- Prepared, labeled, stored and disposed of reagents, and calibrate equipment for research projects.
- Maintain laboratory inventory, including timely ordering and receipt of required supplies and their proper storage.
- Assisted in obtaining educational resources necessary to perform and interpret research and to remain abreast in research area of function.
Education
Bachelor of Science - Biology
Clarion University of PA
Clarion05-2005
Skills
- Documentation review
- Regulatory reporting
- Regulatory submissions
- FDA regulations
- Forms management
- Clinical trials protocols
- Teamwork and collaboration
- Time management
- Attention to detail
- Multitasking
- Reliability
- Excellent communication
- Organizational skills
- Adaptability and flexibility
TBCRC Working Group Co-Chair
Since 2014 I have acted as the liaison between CRS and the Translational Breast Cancer Research Consortium (TBCRC). Opening all TBCRC trials that we have had since that time.
In 2020 I was asked by TBCRC to become 1 of 3 Study Coordinator WG co-chairs and have been serving since that time.
Timeline
Lead Regulatory Specialist
UPMC Hillman Cancer Center -Clinical Research Services
07.2013 - Current
Clinical Research Associate
UPMC Hillman Cancer Center - Clinical Research Services
02.2012 - 07.2013
Research Assistant-Basic Science
Magee-Womens Research Institute of UPMC
09.2007 - 02.2012
Bachelor of Science - Biology
Clarion University of PA