Jennifer Patton Email & Phone Number

Covington, Kentucky, United States

Covington, Kentucky, United States

•Oversee and guide regulatory documents processes and regulatory specific timelines assessments for each study; monitors against study progress and ensures study activity is in compliance with relevant processes; suggests and implements alternative solutions for regulatory issues identified and takes corrective action where necessary•Assess regulatory resources needs and establishes appropriated teams for each study in conjunction with specific study goals, monitors ongoing resources needs against performance•Ensure the timeline milestones and appropriate study maintenance at all stages of study conduct are met•Organize support in case of critical timelines in specific projects and organizes representation for Reg. Specialists in case of vacation or sickness•Provide input for new business development (NBD) proposals and assist or participates in Bid Defense and Capability Meetings•Provide appropriate education and training to CTI staff to maintain up-to-date understanding of International Council for Harmonization (ICH)/Good Clinical Practice (GCP) and other regulatory guidelines•Keep up to date in and review national and international regulatory laws and guidelines regarding regulatory requirements•Attend internal and external study meetings and provide regulatory status reports•Check the status of ongoing studies regarding SSU and eTMF and take care that these are up to date•Organize the check of the eTMF and SSU regarding correct naming and filing as well as completes of regulatory documents•QC and QA of various study related Regulatory documents and reports•Develop or update relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs•Train and mentor less experienced Regulatory staff and other CTI functional staff members•Provide guidance and mentorship to direct reports while overseeing and managing theirwork product•Provide Line management for Regulatory Specialists and coordinators group

Covington, Ky

• Independently manages essential Regulatory documentation for multiple studies or projects and assists with providing guidance and direction to Sponsors and all CTI departments.• Performs / oversees compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Clinical Project Manager (CPM) of any FDA activity documented per CTI Global Standard Operating Procedures (GSOPs).• Compiles / oversees site Regulatory binders being developed according to CTI GSOPs or Sponsor Project-Specific SOPs (PSOPs), performs quality control (QC) review of binders, and ships binders to sites.• Perform / oversees Central Institutional Review Board (IRB) submissions on behalf of Sponsors and sites as agreed to in the scope.• Reviews and comments on informed consent form (ICF) modifications per Sponsor and site requirements for all types of consent forms used during each study (assents, pharmacokinetics [PK], pharmacodynamics [PD], pharmacogenomics [PG], Parental, Health Insurance Portability and accountability Act of 1996 [HIPAA], etc).• Updates ICF content when amendments or study changes require ICF changes and/or modifications.• Interacts with Sponsors as needed, forwarding Regulatory documentation to Sponsors according to CTI GSOPs, Sponsor PSOPs, or scope.• Provides clinical project teams with accurate periodic status reports of in-house documentation.• Performs reviews, reconciliation, close-out, and archiving activities of study documentation according to CTI GSOPs, Sponsor PSOPs, or scope.• Trains and mentors less-experienced Regulatory staff and other CTI functional department staff regarding regulatory work.• QC and quality assurance (QA) of various project-related Regulatory documents and reports.• Represents Regulatory department in capabilities and bid defense presentations.• Prepares for Sponsor or Agency audits and inspections.Along with an array of other activities.

United States

*Perform compliance assessments for all Principal Investigators and IRBs against FDA lists and document any FDA activity discovered. Notify study manager of any FDA activity documented per CTI SOPs *Compile site regulatory binders according to CTI SOPs or Sponsor PSOP; perform a Quality Control review of the binders and ship binders to the sites *Perform central and assist with local IRB submissions on behalf of sponsors and sites as agreed to in the scope *Assist with informed consent form modifications per sponsor and site requirements for all types of consent forms used during each study (Assents, PK, PD, PG, Parental, HIPAA, etc.) *Receive and process study documentation from the sites, assessing accuracy and completeness *Interact with site personnel for document corrections, clarification or resolution of any incomplete and/or incorrect documentation *Accurately log, track and file all correct and complete study documentation *Maintain all essential regulatory documents so that dated documents do not expire throughout the life of each study *Interact with Sponsors as needed, forwarding regulatory documentation to Sponsors according to CTI SOPs or Sponsor SOPs *Attend internal and external study meetings and provide regulatory status reports *Provide the Study Teams with accurate periodic status reports of in-house documentation per CTI SOPs *Perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI SOPs or Sponsor SOPs *Assist with training and mentoring of junior level Regulatory staff and other CTI functional departments *Assist with QC and QA of various study related regulatory documents and reports*Leader for the Quality, Performance and Optimization (QPO) Committee. *Leader for the Technology Initiative Committee *Team Member of the TI Committee (Trial Interactive) Electronic Document Management System.

Cincinnati Area, Ky

• Learned to set up study site files according to CTI GSOPs or Sponsor PSOPs.• Learned to complete compliance assessments for all PIs and IRBs against FDA lists and document any FDA activity discovered; notified supervisor of any FDA activity documented per CTI GSOPs.• Compiled site Regulatory binders with assistance according to CTI GSOPs or Sponsor PSOPs, performed QC review of binders, and shipped binders to sites.• Performed central and local IRB submissions with assistance on behalf of Sponsors and sites as agreed to in the scope.• Gained experience with ICF modifications from sites and began to process ICFs per Sponsor and site requirements for all types of consent forms used during each study (assents, PK, PD, PG, parental, etc).• Received and learned to process study documentation from sites, assessing accuracy and completeness. • Began to interact with site personnel for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation and filed those documents as drafts.• Developed skills to accurately log, track, and file all correct and complete study documentation. • With assistance, interacted with Sponsor as needed, forwarding Regulatory documentation to Sponsor according to CTI GSOP or Sponsor PSOP.Professional Experience continued• Attended internal and external study meetings and developed comfort level in providing Regulatory status reports for each site.• Learned to provide study team with accurate periodic status reports of in-house documentation. • Developed understanding of how to obtain clarifications, corrections, and updated documents as necessary per CTI GSOPs so dated Regulatory documents did not expire throughout life of the study.• Learned to perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI GSOPs or Sponsor PSOPs.

Cincinnati, Ohio

*IRB Responsibilities: Complies with IRB/FDA requirements for study submission, assures compliance with standards and deadlines in notification of subject randomization/enrollment and meets deadlines for progress reports and external safety data.*IRB Responsibilities: Assures compliance with IRB/FDA deadlines for reporting deaths, adverse events and serious adverse events with study subjects. Assures IRB/FDA compliance in facilitating communication between study sponsor and IRB.*Data Management: Create and maintain filing system for trials and perform periodic audit for file completeness. Locate needed documents (i.e. medical records) accurately and confidentially. Utilize time efficiently to gather information from other departments or outside medical systems.*Data Management: Use computer accurately to process data per instructions of supervisor, manager, research nurses and investigators. Maintains and orders supplies for studies in a cost effective manner. Assists with miscellaneous duties designated by supervisor or manager.*Work hand in hand with Investigators to manage their Research Studies.*Keep Department Stats*Create Excel Data bases *Initial start up of Regulatory Binders.*Maintaining the Regulatory Binders. *Submission of Regulatory documents including: Amendments, Revisions, Continuing Reviews, Safety Reports/Adverse Events, Miscellaneous approvals, etc.*Keeping Studies current with the Cooperative or outside group. Example: Faxing all approvals to the CTSU*Obtaining Physicians Signatures on required documents.*Keeping the Investigator certified with the Pharmaceutical Management Branch / NCI by completing a 1572 annually.*Keeping Nurses and Physicians regulatory file up to date. Including Licenses, CV’s and all Training Materials.*Keeping our Share Drive in working order.*Keeping a current Protocol List available.*Ordering department supplies.*Request information from outside offices*Subject follow up and completing CRF's

Good Samaritan Hospital- Kidney And Renal Floor

Responsibilities Included:*Greeting patients and family* Vitals Signs* Assisting patients with daily activites* Straight cathing patients* Stocking linens, nurse servers, medication room* Charting routine checks, I & O’s on patients * Unit Coordinator, answer phone, call lights, place calls to Physicians, enter orders in Meditech system, * Creating charts* Transfer patients for Dialysis

Ludlow, Kentucky

Responsibilities included:* Assisting the Doctor* Checking the patients in/out for appointments* Rescheduling the patients* Obtain and Develope x-rays* Sterilizing Instruments* Filing Charts* Collecting Co-payments and Calling Insurance Companies* Closing the office

Ludlow, Kentucky

Responsibilities included: * Opening and closing the restaurant* Ordering supplies* Running Cash Register* Taking Orders* Cooking/Serving Food* Cleaning Machines

Pca- Nursing, Nursing

High School Diploma

Activities and Societies: Student Counsel Yearbook club Basketball Psychology club

Chemistry

I completed intro classes to enroll into nursing school.