Patricia Pinsonat
Lottie,LA
Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis and recordkeeping abilities.
Overview
36
36
years of professional experience
Work History
Regulatory Associate
University of North Carolina @ Chapel Hill
03.2023 - Current
- Compose regulatory documents for Local and Central Institutional Review Board (IRB) submissions for initial, renewal, amendments, and study close-outs
- Maintain centralized regulatory and study documents in electronic folders
- Correspond with the IRB to resolve stipulations
- Review new study information and begin start-up activities upon site selection
- Access and download Central and Local IRB documents to electronic regulatory folders
- Support clinical research team
- Provide clinical team with amended study information and updates
- Participate in QA activities, monitor visits, and audits
- Independently monitor, plan, and ensure clinical trial deadlines for regulatory submissions are met
- Update department study trackers, weekly meeting agenda and lead weekly department meetings
- Enter data and upload regulatory and study documents in electronic Clinical Trial Management System
- Download study documents for current clinical trials from NCI website
- Review and respond to monitor visit reports
- Compose and submit Corrective and Preventative Action (CAPA) plans to the IRB
- Enter updates to CAPA tracker
- Monitor re-consent plans
- Provide regulatory guidance and training for the clinical research team
- Compose and submit documents for committee reviews and track outcomes
- Ensure IND Safety Reports are distributed to Investigators for review
- Monitor compliance for clinical trials in accordance with regulatory guidelines
- Maintain electronic study documents and regulatory folders
- Correspond with the IRB to resolve stipulations.
Research Regulatory Associate
Actalent/Contract-UNC Research Regulatory Associate
04.2022 - 03.2023
- Compose regulatory documents for Local and Central Institutional Review Board (IRB) submissions for initial, renewal, amendments, and study close-outs
- Maintain centralized regulatory and study documents in electronic folders
- Correspond with the IRB to resolve stipulations
- Review new study information and begin start-up activities upon site selection
- Access and download Central and Local IRB documents to electronic regulatory folders
- Support clinical research team
- Provide clinical team with amended study information and updates
- Participate in QA activities, monitor visits, and audits
- Independently monitor, plan, and ensure clinical trial deadlines for regulatory submissions are met
- Update department study trackers, weekly meeting agenda and lead weekly department meetings
- Enter data and upload regulatory and study documents in electronic Clinical Trial Management System
- Download study documents for current clinical trials from NCI website
- Review and respond to monitor visit reports
- Compose and submit Corrective and Preventative Action (CAPA) plans to the IRB
- Enter updates to CAPA tracker
- Monitor re-consent plans
- Provide regulatory guidance and training for the clinical research team
- Compose and submit documents for committee reviews and track outcomes
- Ensure IND Safety Reports are distributed to Investigators for review
- Monitor compliance for clinical trials in accordance with regulatory guidelines
- Maintain electronic study documents and regulatory folders
- Correspond with the IRB to resolve stipulations.
Clinical Trials Regulatory Coordinator/Sr Clinical Research Coordinator
Baton Rouge General Medical Center
08.2009 - 03.2022
- Conduct Eligibility Criteria review and screen patients for clinical trials
- Access EMR to review and obtain participant medical information for clinical trials
- Conduct the Informed Consent process with patients
- Prepare for Sponsor monitor visits and audits
- Assist physicians with research procedures and surgeries
- Independently monitor, plan, and ensure clinical trial deadlines for regulatory submissions are met
- Ensure clinical trial is conducted according to the IRB approved protocol and timelines
- Compose Serious Adverse Event documentation for submission to Sponsors and the IRB
- Assist physicians with patient visits and collect patient data
- Maintain regulatory binders, drug and medical supply accountability logs, and patient research charts
- Perform patient randomization and navigate patient through study
- Perform phlebotomy and process lab specimens for shipment per protocol
- Completion of patient case report forms and data entry into electronic case report forms
- Prepare study device in surgery for clinical research patients
- Compose regulatory documents for Local and Central Institutional Review Board (IRB) submissions for initial, renewal, amendments, and study close-outs
- Correspond with the IRB to resolve stipulations
- Review new study information and begin start-up activities upon site selection
- Maintain electronic research folders
- Create and track Corrective and Preventive Action plans
- Provide regulatory guidance and training for the clinical research team
- Ensure clinical research team conducts required study activities according to the IRB approved protocol and reports protocol deviations
- Ensure IND Safety Reports are distributed to Investigators for review
- Monitor compliance for clinical trials in accordance with regulatory guidelines
- Perform all work duties and any other tasks assigned.
Medical Certification Specialist II
Louisiana Department of Health and Hospitals
04.2009 - 08.2009
- Certify individuals with disabilities enrolled in the waiver program as medically eligible
- Review recipients individual care plans and goals identified in the plan of care
- Review each individual budget and schedules for recipients in the waiver program
- Conduct home visits, evaluate the environment and equipment in the home for compliance with state and federal laws
- Collaborate with social workers to ensure patients are receiving the appropriate services and care needed to meet their needs.
Research Coordinator/Research Project Manager
LSU- Pennington Biomedical Research Center
08.2003 - 04.2009
- Compose regulatory documents for Local and Central Institutional Review Board (IRB) submissions for initial, renewal, amendments, and study close-outs
- Maintain centralized documents in electronic folders and database
- Correspond with the IRB to resolve stipulations
- Review new study information and begin start-up activities upon selection
- Completion of feasibility questionnaire and coordinate site selection visits
- Patient navigation during clinical trial participation
- Track clinical trial compliance and timelines
- Conduct clinical trial visits and contact patients to adjust medications per protocols
- Conduct Informed Consent process
- Monitor, plan, and ensure clinical trial deadlines for regulatory submissions
- Ensure compliance with HIPAA, Good Clinical Practice Guidelines and Code of Federal Regulations
- Compose Serious Adverse Event reports for Sponsor and IRB submission
- Data entry into electronic case report forms
- Maintain drug and medical supply accountability logs, clinical research patient records, and regulatory binders
- Perform patient randomization
- Assist Sponsors during monitoring visits and audits
- Supervise student workers
- Provided diabetes education to patients in diabetic clinical trials
- Created, organized, and taught diabetes Take-5 classes
- Collaborate and compose care plans for diabetic patients enrolled in diabetes classes.
Registered Nurse/Research Nurse
Woman's Hospital
08.2002 - 08.2003
Medical Supply Manager
Amedisys Incorporated (corporate office)
12.2001 - 08.2002
Director of Nursing
Jefferson Manor Nursing Facility
01.2001 - 12.2001
Registered Nurse Supervisor
Pointe Coupee Nursing Home
08.1999 - 01.2001
Staff Nurse
OB/Gyn and Plastic Surgery Clinic
05.1993 - 08.1999
Staff Nurse/Oncology Research Coordinator
Ochsner Clinic Baton Rouge
09.1990 - 05.1993
Staff Nurse
Baton Rouge General Medical Center
08.1989 - 09.1990
Staff and PRN Nurse
Earl K. Long Medical Center
12.1988 - 01.1990
Education
ASN -
University of the State of New York
06.1997
LPN Diploma -
Memorial Area Vocational School
12.1988
University of Louisiana Lafayette
05.1987
Skills
- Regulatory research
- Regulatory Submissions
- Project Management
- Forms management
- Clinical Trials Protocols
- Submission preparation
- Database Maintenance
- Document Review
References
- Michelle Brignac, St Jude Hospital, Director, (225) 936-2795
- Ivy Adderley, University of North Carolina, Project Manager, (919) 673-8177
- Jane Byrne, Baton Rouge General Medical Center, Manager, (225) 892-8378
- Dawn Rachal, Baton Rouge General Medical Center, Manager, (225) 278-2627
Timeline
Regulatory Associate
University of North Carolina @ Chapel Hill
03.2023 - Current
Research Regulatory Associate
Actalent/Contract-UNC Research Regulatory Associate
04.2022 - 03.2023
Clinical Trials Regulatory Coordinator/Sr Clinical Research Coordinator
Baton Rouge General Medical Center
08.2009 - 03.2022
Medical Certification Specialist II
Louisiana Department of Health and Hospitals
04.2009 - 08.2009
Research Coordinator/Research Project Manager
LSU- Pennington Biomedical Research Center
08.2003 - 04.2009
Registered Nurse/Research Nurse
Woman's Hospital
08.2002 - 08.2003
Medical Supply Manager
Amedisys Incorporated (corporate office)
12.2001 - 08.2002
Director of Nursing
Jefferson Manor Nursing Facility
01.2001 - 12.2001
Registered Nurse Supervisor
Pointe Coupee Nursing Home
08.1999 - 01.2001
Staff Nurse
OB/Gyn and Plastic Surgery Clinic
05.1993 - 08.1999
Staff Nurse/Oncology Research Coordinator
Ochsner Clinic Baton Rouge
09.1990 - 05.1993
Staff Nurse
Baton Rouge General Medical Center
08.1989 - 09.1990
Staff and PRN Nurse
Earl K. Long Medical Center
12.1988 - 01.1990
ASN -
University of the State of New York
LPN Diploma -
Memorial Area Vocational School
University of Louisiana Lafayette
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