Barbara Lepthien

Education

El Dorado High School, Placentia, CA

● High School Diploma

Southern California College of Medical & Dental Careers, Anaheim, CA - 1985 - 1986

●Medical Assisting Diploma

Orange Coast Community College, Costa Mesa, CA - 1981 - 1982

●Associate Arts Degree (Pre-Veterinary Medicine)

Fullerton Community College, Fullerton, CA - 1980 - 1981

●Course Work in Pre-Veterinary Medicine

Experience

National Institute of Clinical Research, Garden Grove, CA 7/2020 - 8/2022

Site Manager / Clinical Research Coordinator

●Overseeing the management of the site and staff.

●Responsible for all pre-site visits and site inhiations.

●Made sure CTMS was up to date on a daily basis.

●Responsible for ordering supplies.

●Responsible for making sure all supplies were available for the start of new studies.

●Took care of phase 1 shifts and any staffing issues.

●Made sure any rooms for phase 1 were clean and disinfected after all patients were done with their stay.

●Met with upper management on a weekly basis to report how each study was moving along and any problems that were seen.

●Responsible for FDA audits and response letters.

Compassionate Cancer Care Medical Group, Fountain Valley, CA 2/2015 - 3/2020

Research Coordinator

●Met with Medical Science Liaisons to discuss different potential studies at the site

●Met with all the monitors from the pharmaceutical companies.

●Responsibilities were to look for trials for the site.

●Schedule all pre-site interviews

●Completing all start and regulatory documents to FDA and IRB.

●Negotiating all budgets and contracts

●Recruiting patients for potential trials

●Completing Phase 1A to 4 trials with the patients. Making sure they were complying with taking IP properly and on time. Making sure they were answering their diaries on time. Reminding them of their appointments.

●Completing all close out documents to IRB and sponsor.

●Created a whole new bindert of Standard Operating Procedures for the site.

Sujata Lalla-Reddy, MD, Fountain Valley, CA 8/2014 - 7/2020

Regulatory Coordinator (part time)

●Responsibilities were working with a third party group to complete offers for new studies.

●Meeting with Medical Science Liaisons and Pharmaceutical representatives to review their research pipeline.

●Completing and submitting all start up documents to the IRB and FDA on behalf of the Investigator.

●Reviewed all Budgets and Contracts with the investigator and negotiated on behalf of the Investigator

●Coordinating patient screening and all appointments until the patient terminated from study.

●Created a whole new set of Standard Operating Procedures for the site.

IMD Medical Group, Los Angeles, CA 7/2013 - 5/2015

Regulatory Coordinator (part time)

●Responsibilities were searching for and recruiting trials for the site

●Completed all pre-site visits for the site.

●Completed all Start up documents to send to the FDA and IRB.

●Negotiated all Budgets and Contracts

●Ordered and supplies the site would need to complete studies

●Created a whole new binder for the site of Standard Operating Procedures.

Aviva Research, Orange, CA

Clinical Research Manager 4/2013 - 2/2015

●Responsibilities looking for potential studies for the site.

●Recruiting potential Physicians for future Investigators for site.

●Ordered supplies for the site to make it ready for Clinical Trials.

●Completed on line applications with pharmaceuticals for Physicians to become potential Investigators.

●Completed all pre-site visits and site initiation for the site.

●Completed all regulatory documents for start up to send to regulating agencies.

●Recruited all patients for trials.

●Completed all close out paperwork for clinical trials.

Allianz Research Institute, Inc., Fountain Valley, CA 2/2010 - 4/2013

Clinical Research Coordinator

●Responsibilities were doing start up to close out with budgets and contracts, regulatory.

●Running the phase 2 to 4 clinical trial and coordinating patient screening and all appointments until the patient terminated from study.

●Met with all the monitors from the pharmaceutical companies.

●Met with Medical Science Liaisons to discuss different potential studies at the site.

●Updated Standard operating procedures at the site

●Created corrective and preventive actions for old studies that needed corrections

Pacific Coast Hematology Oncology Medical Group, Fountain Valley, CA 2//2008- 2//2010

Clinical Research Coordinator

●Met with all the monitors from the pharmaceutical companies.

●Met with Medical Science Liaisons to discuss different potential studies at the site.

●Performed all patient visits and procedures required by the study and delegated to myself.

Pacific Cancer Medical Center, Anaheim, CA 4/1998 - 2/2008

Clinical Research Coordinator/Back Office Medical Assistant/Insurance Department

●Responsible for making sure all the supplies were received prior to study start up.

●Running the trials from phase 1A to 4 and coordinating patient screening and all appointments until the patient terminated from study.

●Completed all data entry for trials assigned to me

●Completed all queries for the trials i was working on.

●Met with all the monitors from the pharmaceutical companies.

●Met with Medical Science Liaisons to discuss different potential studies at the site.

●Roomed patients. Obtained Vital Signs. Drew labs.

●Worked in insurance department. Sending claims. Following up on insurance claims. Verified insurance.

Richard Fayssoux, M.D., Fullerton, CA 4/1996 - 4/1998

Back Office Medical Assistant

●Responsible for ordering supplies and medications.

●Responsible for all back-office procedures.

●Assisted with Bone Marrow Biopsies.

●Performed Phlebotomies on patients Mixed and infused chemo to patients.

●Drew labs and processed them.

●Gave any injections needed.

Jack Brook, M.D., Anaheim, CA 10/1985 - 4/l996

Front/Back Office Medical Assistant/Office Manager

●Responsible for ordering supplies and medications.

●Responsible for all back-office procedures.

●Assisted with Bone Marrow Biopsies.

●Performed Phlebotomies on patients Mixed and infused chemo to patients.

●Drew labs and processed them.

●Gave any injections needed.

●Worked in insurance department. Sending claims. Following up on insurance claims. Verified insurance.

EDC Systems Trained in

Medidata rave

Inform

Data Labs

ClinCapture

EDCLITE

ClinSpark

IRT ClinTrak

Regulatory Systems Trained in

Viva

GSK

eSCODAT

LMS

CTMS

Certificates

●CITI ICH GCP Training - Expires 2/2025

●IATA Certification - Expires 7/2024

●BLS Certification - Expires 8/2024

Skills

Trustworthy

●Good communication with patients.

●Hard worker.

●Goes above and beyond.

●Good communication with other colleagues.

●Completes tasks on time.

●Works well on her own.

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