Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Certification
Timeline
Generic

Kathryn T. Kay

Washington Crossing,PA

Summary

Multi-task, detail-oriented team player capable of coordinating and managing various aspects of clinical trials. Interested in pursuing my future in the industry side of Clinical Research in the a manager position. I am confident that with my years as a Certified Clinical Research Coordinator and my time spent here at ICON I am well prepared to progress not this new position. Work cross functionally on reporting enhancements and process improvements. Initiating and maintaining safety standards Record accuracy in accordance with the most updated GCP/ICH guidelines Team player, great time management skills, prioritizing, etc. Effective multi-tasking but able to be detail oriented Advanced medical terminology knowledge and transcription capabilities / skills Regulatory Document Submission Experience in audits, team management, education of team members Experience in Share point program during last employment position.

Experience in Clinical Trial Master File, Electronic Data Capture Systems Ensure work is performed in accordance with industry standards, federal and state regulations and accreditation standards. Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 18 years of related experience to a challenging new role.

Dedicated clinical research professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.


Overview

20
20
years of professional experience
1
1
Certification

Work History

House Clinical Research Associate

ICON Clinical Research
03.2021 - Current
  • Maintain timelines and ensure accuracy and completeness of data entered in the ICON systems
  • Serves at the primary in-house contact for sites and investigators participating in the sites
  • Conduct and complete remote site management activities providing support to the sites as needed
  • Contact clinical sites for specific requests (i.e
  • Enrollment updates, missing documentation, data entry timelines or other sponsor specific issues)
  • Contact sites regarding query follow ups, CDA finding follow-up and action item resolution or other sponsor specific CRA tasks
  • Take responsibility for project tasks and see the tasks through completion
  • Maintain professional and interpersonal relationship with study team, sites and sponsors
  • Participate in QA audits as needed
  • Regularly attend and provides feedback during team meetings
  • Maintain sponsor and patient confidentiality
  • Other duties as assigned.

PA Certified Emergency Medical Technician Instructor

BCCC
05.1995 - Current
  • Provide instruction and evaluation for students enrolled in the EMT course at Bucks County Community
  • College sponsored by the National Registered EMT program
  • Participate in planning, implementation and execution of new curriculum editions, involved in two pilot programs with Brady publishing for the
  • EMT course nationally
  • Supervise and evaluate students involved in the national registered EMT program for competency, knowledge, documentation skills as well as practice medical assessment and medical skills
  • Also offer remediation and tutoring if needed as well as practical precepting knowledge in the ems community with ambulance companies.

Administrative assistant to Vice President

Upper Makefield Fire Company
Washington Crossing, PA
01.1995 - Current
  • Of Sales and Marketing
  • I was responsible for email correspondence, billing for products, professional calendar, international calls and meeting schedules using business Skype programs, etc
  • Responsibilities also included receipt for product shipments, liaison between VP of sales and manufacturing floor
  • Instrumental in establishing more efficient work-flow of manufacturing, shipping and receiving products
  • Other duties included power point presentation, sales calls to large companies for follow up, etc
  • Arrange travel for VP and myself to showcase products at international and national trade shows., 24-year associate and professional contributing member assisting with auxiliary projects and programs including but not limited to fundraising, providing rehabilitation resources to firefighters.

Clinical Trial Associate

ICON Clinical Research
05.2018 - 03.2021
  • In my position I support to two Oncology projects; one trial as the Global CTA and the other trial I am allocated at 2FTE
  • I maintain and track clinical study documentation within eTMF (Icomaster); BOX and eRoom usage
  • Initiate, perform, review and supply support for eTMF QCs to with ICON and Sponsor
  • I have been able to establish professional relationships with my ICON team, study teams and the sponsor that have provided a straightforward way to resolve queries and other issues efficiently
  • I also lend support to the CRAs internationally for both studies by granting site user access, document filing, etc
  • I have and willing to perform any tasks requested by PM, CTM and other team members.

Senior Clinical Research Coordinator

Synexus – US
Hatboro, PA
01.2017 - 02.2018
  • As delegated by the principal investigator, executed and coordinates daily clinical research activities according to CRA’s, SOPs, GCP and FDA/ICH guidelines
  • Oversees smooth site operations with ancillary staff as well as investigators
  • Ensured IRB approved protocols are implemented and followed
  • Executed informed consent process along with principal and sub-investigators
  • Implemented recruitment and retention plans for trials
  • Monitors patient safety; collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; education of patients and their families about treatment, possible side effects and has general operational responsibilities for the site
  • Typically performed tasks such as site preparation, patient screening and recruitment, enrollment and retention, study visits, maintaining and dispensing study products and supplies as well as budget and contract negotiations
  • Responsible for payments to patients within CTMS system
  • Completes and ensures the quality of source documents, quality of complete source documentation as well as completion of Ecrfs, and responding to queries., Diassessis / Influenza point of care testing

Certified Clinical Research Coordinator

LPS Durham Physicians
Levittown, PA
02.2011 - 01.2017
  • Coordinating with Principal Investigator to help ensure that the clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
  • Reviews and develops a familiarity with protocol, e.g
  • Study procedures and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
  • Responsible for coordinating and implementing procedures to collect data from paper and electronic medical records, patient interviews, diagnostic tests and other sources
  • Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and / or inconsistencies and monitor patient’s progress to include documentation and reporting of adverse events; recommend correct active action as appropriate
  • Work closely with sponsor, monitoring and other study personnel on the trial from regulatory, risk-based monitoring, etc
  • Responsible for clinical trial from feasibility to close out visits
  • These activities were performed in an established primary care practice in conjunction with working closely with the clinical research institute colleagues located at Saint Mary Medical Center in Langhorne, PA.

Warminster Volunteer Ambulance Corps
Warminster, PA
01.1990 - 01.2015
  • Life member status, served as senior corpsman for 10 years of Advanced Life Support ambulance with volunteering weekly, board of director’s member for 5 years and line officer, captain rank for 4 years of active duty.

Council Rock Youth Lacrosse Association
Newtown, PA
01.2010 - 01.2013
  • Of booster club executive board as secretary for 3 years
  • Kept detailed and well documented board meeting minutes, communication for parents, newsletters, community outreach programs and chairperson of major fundraiser for program for three years.

Certified Clinical Research Coordinator

Gringeri Family Medicine
Newtown, PA
04.2003 - 01.2011
  • Coordinating with Principal Investigator to help ensure that the clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
  • Reviews and develops a familiarity with protocol, e.g
  • Study procedures and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
  • Responsible for coordinating and implementing procedures to collect data from paper and electronic medical records, patient interviews, diagnostic tests and other sources
  • Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and / or inconsistencies and monitor patient’s progress to include documentation and reporting of adverse events; recommend correct active action as appropriate
  • Work closely with sponsor, monitoring and other study personnel on the trial from regulatory, risk-based monitoring, etc
  • Responsible for clinical trial from feasibility to close out visits.

board member

Crossing Cooperative Nursery School
Washington Crossing, PA
01.2001 - 01.2005
  • For 3 years as secretary and volunteer coordinator
  • Responsible for keeping detailed documented minutes for all board meetings; relaying school happenings in newsletter, email communications to parents as well as implementing safety policies and procedures which included training teachers, support staff in CPR and fundraising to get AED on site with training.

Administrative Assistant to the President

Rapid Deployment Products, Inc
02.2000 - 01.2003
  • Generated reports and typed letters in Word and prepared PowerPoint presentations.
  • Interacted with vendors, contractors and professional services personnel to receive orders, direct activities and communicate instructions.
  • Monitored supervisor's work calendar and scheduled appointments, meetings and travel.
  • Developed and updated spreadsheets and databases to track, analyze and report on performance and sales data.
  • Supported efficient meetings by organizing spaces and materials, documenting discussions and distributing meeting notes.
  • Processed invoices and expenses using QuickBooks to facilitate on-time payment.
  • Coordinated travel arrangements by booking airfare, hotel and ground transportation.
  • Managed Access databases converting complex data into easy-to-interpret data.

Office Manager / Instructor Trainer

CPR Heart Starters, Inc
02.2000 - 01.2003
  • Managed team of fifty CPR /First Aid Instructor as well as emergency medical services professionals
  • Handled incoming / outgoing correspondence including emails, mail, faxes, courier documents
  • Devised and maintained office systems to efficiently deal with workflow
  • Coordinator overnight travel arrangements and accommodations for instructors
  • Organized personal and professional calendars amongst the instructor pool
  • Implemented policies and procedures for instructor teams to abide by regulations for each industrial area they would train in
  • As well as offered training programs to help employees maintain and improve job skills
  • Evaluated training materials prepared by instructors
  • Monitored training costs, created budget reports for management
  • Monitored training lectures, discussions and demonstrations are CPR, First Aid, OSHA and workplace safety training
  • Conducted small group activities based on differentiated learning needs.

Medical Assistant / Chemotherapy Technician

Bucks County Multi
Washington Crossing, PA
01.1992 - 01.2000
  • Specialty Group
  • Kathryn T
  • Kay, EMT-I, AHA-I, CCRP 1088, 8515 | goalielaxmom01@gmail.com
  • Worked in a multi-specialty practice consisting of three physicians; two non-interventional cardiologists and one hematologist/oncologist
  • Worked closely with patients and physicians in administering medical services
  • Scheduling medical procedures with hospital and ancillary staff; phlebotomy procedures; patient intake, medical history and record review
  • As well as performed ECGs, non-nuclear stress test
  • Administering chemotherapy treatments via intravenous methods, trained in specific access for porta
  • Cath use, etc.

Emergency Department Technician

Warminster Hospital
06.1990 - 01.1992
  • Phlebotomy procedures, coordinating ancillary staff needs for patients in emergency situations, wound care, splinting, ECG monitoring, triage patient, as well as handling patient care between hospital and pre-hospital staff.

Education

Bachelor of Science - Health Information

Indiana University - Purdue University Indianapolis
Indianapolis, IN
03.2023

American Heart Association Certified Healthcare BLS, Heartsaver And First Aid Instructor - Basic Life Support

Bucks County Community College
Newtown, Pennsylvania
1995

Pennsylvania State Emergency Medical Technician Certification and Instructor - undefined

Bucks County Community College
1995

Skills

  • Schedule Monitoring
  • Product Inventories
  • Environmental Compliance
  • Patient Safety
  • Reading Comprehension
  • Document Verification
  • Site and Study Management
  • Trial Methodologies
  • Trial Close
  • Team Meetings
  • Monitoring Visits
  • Site Evaluations

Accomplishments

  • Certifications:
  • 1995: Certified American Heart Association CPR and First Aid Instructor
  • 1991: Certified Emergency Medical Technician / Instructor
  • 2007: Certified Clinical Research Coordinator, ACRP
  • 2013: Certified Clinical Research Professional, SOCRA
  • 2014: Certified Medical Assistant
  • 2017: Certified in IATA, expires 2019
  • 2017: CITI Training certified, expires 2020
  • Skill Highlights
  • Develop and maintain a good working knowledge of relevant protocols
  • Perform essential support for clinical research throughout all stages of a project
  • Detail note taking / data compilation / documentation (written and electronic format)
  • Perform essential support for clinical research throughout all stages of a project
  • Performs data entry into the CTMS system for study or client information
  • Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
  • Able to effectively plan and coordinate clinical research projects
  • Carefully review documentation and participant information to quickly spot and address problems
  • Hardworking and reliable focused on going above and beyond to support team and serve customers
  • Computer Literature: Good Knowledge at user level of Microsoft Office
  • Proficiency in
  • Microsoft applications
  • Kathryn T
  • Kay, EMT-I, AHA-I, CCRP

Affiliations

Life Member of Upper Makefield Volunter Fire Company


Certification

Emergency Medical Technician since 1991

Emergency Medical Technician Instructor since 1995

AHA BLS/HCP Instructor

SOCRA certification

Timeline

House Clinical Research Associate

ICON Clinical Research
03.2021 - Current

Clinical Trial Associate

ICON Clinical Research
05.2018 - 03.2021

Senior Clinical Research Coordinator

Synexus – US
01.2017 - 02.2018

Certified Clinical Research Coordinator

LPS Durham Physicians
02.2011 - 01.2017

Council Rock Youth Lacrosse Association
01.2010 - 01.2013

Certified Clinical Research Coordinator

Gringeri Family Medicine
04.2003 - 01.2011

board member

Crossing Cooperative Nursery School
01.2001 - 01.2005

Administrative Assistant to the President

Rapid Deployment Products, Inc
02.2000 - 01.2003

Office Manager / Instructor Trainer

CPR Heart Starters, Inc
02.2000 - 01.2003

PA Certified Emergency Medical Technician Instructor

BCCC
05.1995 - Current

Administrative assistant to Vice President

Upper Makefield Fire Company
01.1995 - Current

Medical Assistant / Chemotherapy Technician

Bucks County Multi
01.1992 - 01.2000

Emergency Department Technician

Warminster Hospital
06.1990 - 01.1992

Warminster Volunteer Ambulance Corps
01.1990 - 01.2015

Bachelor of Science - Health Information

Indiana University - Purdue University Indianapolis

American Heart Association Certified Healthcare BLS, Heartsaver And First Aid Instructor - Basic Life Support

Bucks County Community College

Pennsylvania State Emergency Medical Technician Certification and Instructor - undefined

Bucks County Community College

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Kathryn T. Kay