Laura Lyon

**** ********* ** *******, ** *****

Phone: 901-***-**** E-Mail: acz4ez@r.postjobfree.com

OBJECTIVE

Coordinate, administer and plan research studies by ensuring that the work scope, study protocol and regulatory requirements are followed. Dedicating and ensuring the patients' safety by following the protocol provides medical companies (sponsors) and the FDA the information needed to find out if a new treatment is truly beneficial to future patients. It's a career of great importance that I find it to be very challenging, exciting and rewarding. I’m seeking a clinical research position to be involved in the future of cutting edge medical treatments.

SUMMARY

•Energetic, highly motivated professional who led as primary coordinator on psychiatric research trials involving patients with Alzheimer’s, Schizophrenia, Bipolar, ADHD, Depression and Tourette’s syndrome

•Sponsors include Neurocrine, Merck, Novartis and Takeda

•Knowledge of the investigational product development process and participated in process improvement

•Developed clinical study documents including recruitment plans, screening plans, source documents and CRFs

•Reviewed informed consent and amendments for compliance with site standard operating procedures

•Maintained a study status report including screen fails, enrollments, early terminations, completion and follow ups

•Primary submission of clinical data and regulatory documents to Sponsor and IRB

•Ensured adherence to protocol and regulatory compliance

•Familiarity with Safety and Clinical Trial related databases

•Proficient with eCRF’s, data entry, Microsoft Office, Excel, PowerPoint and multiple electronic database portals

•Knowledge of federal, state regulations and protocol compliance under auspices of the Principle Investigator

•Excellent verbal and written communication skills and ability to interact effectively in a team environment

•Highly organized, self directed and demonstrates attention to detail

•Demonstrates accountability for delivery of results, have good problem-solving and decision making skills

•Able to manage own work, with ability to prioritize, plan and organize work assignments under timelines

•Follows established processes and has flexibility to adopt new practices and priorities as required

•Ability to work collaboratively as part of a team in a fast paced dynamic environment

EDUCATION

University of Memphis: Bachelor of Science, Health Promotion and Lifestyle Management August 201

Cambridge HealthTech Barnett Educational International: CRC Certification October 2013

EMPLOYMENT HISTORY

Practice Research Organization, Dallas, TX: Clinical Research Coordinator-OBGYN January 2016-December 2016

•Obtained informed consents forms

•Created and maintained regulatory documents, study related materials and case report forms

•Primary correspondent with monitor, vendors, sponsor representatives and study site personnel

•Organized and maintained Investigator’s Trial Master Files

•Provided protocol specific activities including phlebotomy and assisted PI with subject examinations

•Processed and shipped all laboratory assessments to central lab including ordering study specific supplies

•Scheduled subjects for all study and follow up visits

•Routinely collaborated with Monitors to complete outstanding action items and queries

•Involved in patient recruitment and enrollment materials

•Updated patient records including medical history, adverse events and concomitant medications

University Hills Clinical Research, Dallas, TX: Clinical Research Coordinator-Psychiatry January 2015-December 2015

•Obtained informed consent forms

•Prepared and submitted regulatory documents to Institutional Review Boards/Ethics Committee

•Maintained Investigator Trial Master Files

•Primary correspondent with sponsor representatives, monitors, vendors, and other essential study personnel

•Maintained all regulatory and study related materials

•Conducted protocol specific activities including ECG’s and video recordings

•Processed and shipped all laboratory assessments to central lab including ordering study specific supplies

•Scheduled subjects for all study and follow up visits

•Dispensed study medication and maintained drug accountability records

•Completed all written and electronic case report forms

Diane Abbey DDS Dental Clinic, Memphis, TN: Intern June 2013-August 2013

•Assisted dentist, dental technicians and hygienist in routine dental procedures

•Trained patients on oral health techniques recommended by the American Dental Association

•Conducted procedures to obtain oral cavity x-rays and film development

•Conducted procedures for sterilization of operative instruments

•Assisted in administrative duties such as scheduled patients and filed medical records

•Maintained a clean and safe office environment

Leitherland Family Care Clinic, Dyer, TN: Office Coordinator/Medical Assistant May 2012-May 2013

•Managed and organized front desk and office supplies

•Filed and updated patient medical records and verified insurance information

•Scheduled patient’s visits, specialty radiograph procedures and referral appointments

•Processed samples for laboratory analysis and shipped to reference laboratory

•Obtained vital signs

•Assisted physician with patients when needed

CERTIFICATIONS

•ICH/Good Clinical Practice- National Institute of Health

•Protecting Human Research Participants- National Institute of Health

•Ethics, Principles-Office for Human Research Protection (OHRP)

•Shipping and Transporting Dangerous Goods- Mayo Clinic

•Shipping Biological Substances, Infectious Substances and Related Hazards-IATA/ICAO

•Transporting Dangerous Goods through P.A.C.E- American Society for Clinical Laboratory Science

•Colombia Suicide Severity Rating Scale- Research Foundation for Mental Hygiene, Inc.

•Clinical Research Coordinator training- Boston Scientific

•Live Trial Site General Overview and Supply Management-Health Decisions

•Datalabs EDC Site Entry training- Perceptive Institute

•Clinical Portal And Collaboration Training for Site Personnel

•Site Budget Course

•Adverse Experience Reporting Training

•Privacy Protection in Clinical Trials

•Fraud and Misconduct in Clinical Research

•Videography training- Clinilabs

•CPR/First Aid- University of Memphis

MEMBERSHIPS, ORGANIZATIONS, AND VOLUNTEER WORK

•Society of Clinical Research Associates (SOCRA)

•Association of Clinical Research Professionals (ACRP)

•Drug Information Association (DIA)

•Health Promotion Student Organization

•Campus Crusades for Christ

•American College of Sports Medicine

•American Cancer Society: Relay for Life Committee

•National Down Syndrome Society

•Habitat for Humanity

•Zeta Tau Alpha: Susan G Komen Breast Cancer Research

•Captain Hope’s Kids

•Make A Wish North Texas

•The Stewpot at The Bridge: Dallas Homeless Assistance Center

Contact this candidate