Assistant Clinical

Randee L. Sobel

*** ******* ****, ***** *******, PA 19002

Phone: 215-***-**** • E mail: r ******@*****.***

SUM MARY

Extensive experience in Clinical trial management including compliance and quality

control of Regulatory Documentation, ICH /GCP practices, feasibility for trial site

selection, operational engagement, trial maintenance and regulatory documentation

f iling.

PROFESSIONAL H ISTORY

Business Development University, Ambler, PA 2012-Present

Consultant

M arketing Coordinator

• Executive Administrative functions to CEO and COO.

• Coordinate teleconferences with marketing staff and C- level executives

• Coordinate various vendors including computer consultants, graphic designers video

p roduction and facilities for t raining classes

• Streamlined office functions to improve efficiencies resulting in dramatic operational

i mprovements

ReSearch Pharmaceutical Services, I nc. F t Washington, PA 2009 –

2012

I nvestigator Document Associate

• Processing of essential clinical t r ial documents to facilitate study startup.

• Assemble components required from Start-Up to completion of study.

• Conduct Q uality Assurance reviews across all Therapeutic a reas and maintained

appropriate audit t rails for key documents through the life of the t r ial.

Received 5 Peer Awards for ability to provide information and guidance

to group members

Sponsor Award for contributions to crucial tr ial; completed ahead of

study timelines.

Chairman of I nterview Committee

Pharmanet, L LC, Blue Bell, PA 2005 –

2009

Sr. Clinical Research Assistant (2006 – 2009)

Clinical T rial Assistant ( 2005 – 2006)

• Coordinate with senior staff with all in-house activit ies for Phase I I I to IV clinical

t r ials

• Reviewed regulatory and administrative documents from all trial sites

• Coordinated t he clinical project team w ith regard to regulatory documentation for

clinical t r ials

• Assure currency of required clinical t r ial documents within Central Files (i.e. CV’s,

FDA 1572, Lab Certifications and Normals, Financial Disclosures)

• Collect and disburse all SAE’s to sites and Pharmanet Global.

COMPUTER EXPER IENCE

Windows XP, W indows 7, M S Office products (including M icrosoft Outlook Word, Excel,

Powerpoint, Outlook), PROMIS, Cognos Reporting, CTMS, Impact, Documentum,

Sharepoint. F irst Doc, WordPress, eroom

E DUCAT ION

Bachelor of Arts - Temple University - Philadelphia, PA

Contact this candidate