Clinical Research Trials

E. Sorley CV version: **-May-****

Eva Sorley

EMS Clinical Research, LLC

Clinical Research Associate

Greenville / Spartanburg, SC

Mobile: 919-***-**** adycqf@r.postjobfree.com

THERAPEUTIC EXPERIENCE:

• Phase I, II, III, IV Clinical trials:

o Years: >10 years

• Oncology – (Breast, Pancreatic, Ovarian, Non-small cell lung, Gastrointestinal, Prostate, Refractory/Recurrent Peripheral T-cell Lymphoma, CLL, MML, MDS, Head/Neck, Solid tumor, Rare Tumor/Orphan Disease) o Years: >10 years

• Oncology – Phase I PI initiated clinical trials: (Rare Tumor, Solid Tumor with ARID1A Mutation) o Years: >6 years

• Ophthalmology – (Retinal Diseases, AMD, Stargardt’s disease, Fuchs’ Dystrophy, Diabetic Retinopathy) o Years: >10 years

o Surgical / Clinical Experience: Retinopathy of Prematurity, CMV Retinitis, Retinal Detachment, Retinoblastoma, Glaucoma, Oculoplastic Reconstruction, ICG/Fluorescein Angiography o Years: >16 years

• Dermatology – (Giant Plaque Psoriasis)

o Years: 4 years

• Cardiovascular – (de-novo stenting in patients with Cardiovascular Artery Disease (utilizing chemotherapy agent), Hypertension, Angina

o Years: 4 years

• Gastroenterology – IBS, IBD/Cohn’s disease

o Years: 5 years

• Infectious Disease – (HIV)

o Years: 5 years

• Pain management, Opioid Dependence

o Years: 5 years

• Endocrinology – Gout, Rheumatoid arthritis, Chronic renal failure / Anemia, Type II IDDM, Type II NIDDM o Years: 4 years

• Remote data review

o Years: >8 years

• Site monitoring / Site management

o Years: >10 years

• Site selection/Pre-study/SIV

o Years: >10 years

• Site Closeout

o Years >8 years

EDUCATION:

• BS - University of Arizona – Tucson, Arizona

• AA - Cochise College – Sierra Vista, Arizona

• CST - Bryman School – Phoenix, Arizona

COMPUTER EXPERIENCE:

• Microsoft Outlook, Word, Excel, PowerPoint

ELECTRONIC DATA CAPTURE:

• Phase Forward (Inform / InfoLink), Medi-data Rave, Medrio, eCaselink, Data lab, RedCap E. Sorley CV version: 08-May-2023

EXPERIENCE:

07/2007 – Present

EMS Clinical Research, LLC

Independent Clinical Research Consultant

Greenville, SC

• Independent clinical contract monitor employed by various Pharmaceutical and Biotech companies, as well as Clinical Research Organizations.

• Monitor clinical trials in a variety of therapeutic areas for high enrolling, rapid enrolling study sites.

• Successfully monitor PI initiated clinical trials.

• Site selection, Pre-study site visits, Initiation, regular monitoring/site management, Site close-out

• Highly effective in motivating slow or delinquent sites.

• Highly successful in “messy site” cleanup.

• Ensure compliance with ICH federal regulations, GCP, and client SOP’s.

• Conduct Investigational Product Accountability, Regulatory Document Review, and IRB/WIRB compliance.

• Verify accuracy of source documentation and validity of CRF entries.

• Risk based monitoring / Remote Data Review.

• Query resolution and reconciliation of AE/SAE’s.

• Resource and direct contact for the clinical site and research team. 9/2003 – 7/2007

Formerly: Abraxis BioScience, Inc.

CRA III, Senior CRA

Raleigh, North Carolina

• Lead CRA - mentored junior CRA’s, reviewed monitoring visit report and letters, presented weekly updates to project teams

• Assisted Clinical Trials Manager with various activities and tasks including site selection, Investigator meetings, protocol review, study contract / budget, monitoring plan development.

• Developed power point presentation for site initiation visits.

• Conducted pre-study, initiation, monitoring, and close-out visits to study sites while ensuring compliance with federal regulations and ABI’s SOPs/monitoring guidelines

• Verified source documentation and validity of CRF entries, while assisting with query resolution

• Reconciliation of AE/SAEs.

• Conducted Investigational Product Accountability, Regulatory Document Review

• Maintained a working knowledge of GCP/ICH, ABI SOP’s, and protocol-related specifics

• Served as a resource for investigative site personnel and ABI project teams

• Facilitated effective communication between investigative sites and the project team via written, oral, and /or electronic contacts

• Provided insight to Data Management on CRF completion guidelines, standardization of CRF templates for all studies. Developed a CRF tracking system

4/2001 – 9/2003

Pharmalink FHI

CRA I, CRA II

RTP, North Carolina

• Monitor electronic data capture clinical trials for phase II and III trials, in Ophthalmology, Oncology and Dermatology

• Responsible for overseeing the progress of clinical research projects and ensuring investigative sites are conducting the project within the requirements of the clinical protocol, federal regulations and guidelines for electronic data capture.

• Conduct pre-study, initiation, interim monitoring, and close-out visits to study sites

• Ensure compliance with IRB / WIRB, ICH federal regulations, GCP, and client SOP’s

• Conduct Investigational Product Accountability and Regulatory Document Review

• Verify accuracy of source documentation and validity of CRF entries

• Assist with query resolution and reconciliation of AE/SAE’s

• Serve as a resource and direct contact for the clinical site and research team E. Sorley CV version: 08-May-2023

• Timely completion of all required study tasks in order to maintain study timelines

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