Technician Data

LAUREN ROBISON

**** ***** **** ******, ****, NC

Email: **************@*****.*** 801-***-****

OBJECTIVE

Seeking a clinical research position in the pharmaceutical and/or

biotechnology field that will purposefully utilize my qualifications

while offering opportunities to integrate personal enrichment with

professional goals.

EDUCATION

Bachelor of Science

Utah State University, Logan, Utah December 2003

Major: Biology Minor: Philosophy (Biomedical Ethics)

SKILLS

Qualifications:

Excellent problem solving and critical thinking skills,

extremely detail oriented, great understanding of monitoring

procedures and clinical trial processes, extensive knowledge of

FDA, ICH, GCP, CMS and other industry guidelines/regulations.

Computer:

Proficient in Microsoft Word, Excel, PowerPoint, Access, Adobe,

WordPerfect, Publisher, SAS, DataFax, ClinPlus, internet

research, and various database systems.

EXPERIENCE

Intermountain Donor Services

2009-present

Quality Improvement Salt

Lake City, UT

Direct and coordinate the clinical activities of the program to

ensure compliance with acceptable standards of practice,

including FDA, AATB, CMS, and AOPO. Perform various audits

(internally and externally) to ensure quality standards are

being met. Create policies and procedures, clinical forms,

audits, reports, etc. Oversee participation in research trials.

Track and report adverse events. Determine donor suitability by

review of medical/social history, lab results, consent forms,

and inclusion/exclusion criteria.

ZARS Pharma

2008

Clinical Data Specialist Salt

Lake City, UT

Responsible for working in all stages of the clinical trials

process. Create and resolve queries, track and report adverse

events, collect regulatory documentation. Design CRFs, write

completion guidelines, design and test clinical databases

(including edit check programs). Review source documents and

other types of clinical data for accuracy and completion.

Maintain accordance with 21 CFR Part 11 (GCP).

Myriad Pharmaceuticals

2005-2008

Clinical Data Coordinator

Salt Lake City, UT

Work in conjunction with PIs, CRCs, and CRAs in protocol

understanding and adherence, through on-site visits and

teleconferences. Lead both the generation and the resolution of

queries. Worked with data managers to coordinate and monitor the

flow of clinical data into the computer database by analyzing

and evaluating clinical data, recognizing inconsistencies, and

initiating the resolution of data problems. Create various

documents, including CRF Guidelines and DCFs. Performed various

monitoring duties including site close-out visits, source

document verification, and regulatory document collection. Lead

on Myriad's Phase III Open Label rollover trial.

Myriad Genetics

Lab Technician

Followed detailed procedures for DNA extraction (Quiagen

method). Used sample database to crosscheck and troubleshoot.

Complied with clean-room lab regulations.

CBR Systems, Cord Blood Registry

2004-2005

Processing Technician

Tucson, AZ

Prepared umbilical cord blood for processing. Separated,

harvested and recombined cells, and checked for viability and

sterility. Took cell counts using hemacytometer. Stored stem

cells by cryopreservation.

Utah State University

2003

Genetics Tutor, Multicultural Student Union

Logan, UT

Explained concepts from questions posed by students from the

Genetics (Biol 3200) class. Scheduled/arranged tutoring

sessions. Prepared example questions to test students practical

knowledge of genetics, outside of prepared class material.

ACTIVITIES

Self Study, The CRA's Guide to Monitoring Clinical Research (2010)

Clinical Research Coordinator Basic Training Course, University of

Utah (2008)

Consultant, Aspen Falls Spinal Care Center (2009 - present)

Volunteer, ReachOut Pregnancy Crisis Center (2004-2005)

OSHA Safety Training Certification, University of Arizona (2004)

Volunteer, Intermountain Health Care Hospital (1996-2000)

References available upon request.

Contact this candidate