Clinical Research Training

Shanel Nelson, ct/ccrp

***** ****** **** *** **** San Antonio, TX 78216

334-***-**** ? ******.******@*****.***

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Summary

ASCP Certified Cytotechnologist with experience screening and accurately

diagnosing gynecological and non-gynecological cytology samples. Certified

Clinical Research Professional with experience monitoring Phase II & III

clinical trials over several therapeutic areas. Knowledge of FDA

regulations and ICH-GCP guidelines. Excellent communication and

presentation skills.

Therapeutic Experience

? Infectious Disease ? Women's Health

? Oncology ? Dermatology- Wound Healing/ Ulcers

Professional Experience

Cytotechnologist Jan. 2009 - Present

Center for Disease Detection, San Antonio, TX

. Diagnosing 10.5-12 gynecological cases per hour

. Screening and evaluating any gynecologic and non-gynecologic specimen

sent to the laboratory for the determination of possible malignant or

related abnormal conditions

. Preparing slides containing sample cells for examination under a

microscope

. Evaluating cells for the presence of cancer, precancerous changes or

infections

. Providing interpretation of all patient samples to the pathologist

Clinical Research Associate Oct. 2006 - Dec. 2007

Caligeo Clinical CRO, Montgomery, AL

. Monitored clinical studies in accordance with sponsor's protocol and

GCPs to assess the safety and efficacy of investigational products

. Conducted site visits (i.e., Site Selection Visit, Initiation Visit,

Interim Monitoring Visit, and Close Out Visits) to determine protocol

and regulatory compliance, and prepared required documentation

. Verified and ensured proper preparation, handling, accountability and

distribution of test materials

. Reviewed and tracked regulatory documents; and the verification of

data management queries in order to meet clinical study timelines

. Applied FDA regulations and ICH-GCP guidelines to all aspects of

clinical studies including but not limited to: protocol compliance,

IRB submissions, informed consent review and revise, handling adverse

events, statistical data analysis and interpretation to ensure safety

and protection of study participants and enhanced product credibility

. Assisted Project Managers in creating and reviewing study templates

and documents such as subject visit calendar, study financial/budget

forms, payment requests, invoices and contractual agreements

. Familiar with RECIST

Education

Capella University- Candidate December 2010

MBA Candidate - Finance

Auburn University Montgomery- Graduate December 2008

B.S. - Biology/Concentration in Cytotechnology

Auburn University- Graduate December 2007

B.S. - Biomedical Science

Professional Training

Cytotechnology Clinical Training

University of Alabama in Birmingham, AL

. Screened GYN cases

. Screened NGYN cases

. Observed and assisted with FNA procedures

. GYN cytopreparatory techniques including Thin Prep processing,

staining and cover slipping

. NGYN cytopreparatory techniques including but not limited to BAL, CSF,

FNA, fluids, bronchial brushing, bronchial washing, and sputum's

. Familiar with cytospin, vortex and centrifugation machines

Fundamentals of Pharmaceutical Research for CRAs and CRCs

Caligeo Clinical, CRO

. Knowledge of ICH/GCP

. Regulatory Compliance

. Monitoring Training (Pre-Study, Initiation, Interim, and Close-Out

Visits)

. Site Management Skills

. Medical Terminology

Computer Skills

. Microsoft Office Suite (Word, Excel and PowerPoint)

. DataTrak

Professional Organizations

Society of Clinical Research Associates (SoCRA #34993) Member

since 2009

American Society for Clinical Pathology Member since

2008

Americ an Society for Cytotechnology Member since

2008

Contact this candidate