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.
• 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

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.
• 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].
• Updates ICF content when amendments or study changes require ICF changes and/or modifications.

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.

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.

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.

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*.

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.