Manager Clinical Research

Neha Purohit

**** ****** **. #***** 858-***-**** ************@*****.***

Houston, TX 77098

Summary of Experience: From 2007-2009, I have worked for PAREXEL International as an in-house

Clinical Research Associate, following four years in the pharmaceutical industry. I started my career in

Laboratory Research and transitioned to Clinical after five years. My therapeutic experience includes infectious

disease (HIV), oncology, and CNS (Alzheimer’s disease) studies. Currently I am working as a QA Manager for

a Site Management Organization (SMO) involved with five Principal Investigators in the Houston are.

Employment History:

Spring Clinical Research

Houston, TX

QA Manager

Current

• Perform quality control on source documentation for various clinical studies the SMO is participating in

with five Principal Investigators

• Conduct a quality check on both paper and electronic case report forms

• Revise regulatory documents such as FDA form 1572 and Financial disclosure forms for Principal

Investigator

• Attend all monitoring visits to ensure Clinical Research Associate’s questions/ concerns are answered

promptly

• Manage six Study Coordinators to ensure proper training on different studies

• Responsible for assuring queries are answered appropriately in a timely manner

• Support Site Management Organization Manager with other study related tasks

PAREXEL International

San Diego, CA

Clinical Research Associate- In House

2007 – 2009

• Lead Clinical Research Assistant on a Phase III Cardiology, Phase III Oncology, Phase IIIB

Central Nervous System, and Phase II Infectious Disease studies

• Assisted a Clinical Research Associate II on interim-monitoring visits for high enrolling sites in a

Phase III Cardiology study

• Submission and review of protocol, informed consent, and recruitment material for sites using

Local and Central Institutional Review Boards including WIRB and COAST to ensure prompt approval

• Support Clinical Research Associates and site investigators to ensure adherence to good clinical

practices and FDA regulations

• Traveled to several investigator meetings nationwide where I interacted with physicians, Clinical

Research Associates, Clinical Leads, and the Sponsor

• Coordination and implementation of in-house monitoring activities including collection, review,

and tracking of regulatory documents such as FDA form 1572 and Financial Disclosure Forms

• Provide in-depth training to current and new project team members, including Clinical Leads,

Clinical Research Associates, and Clinical Research Assistants on internal systems for document

tracking, project specific maintenance plan, and updating website for Sponsor viewing of project

deliverables

• Worked in close contact with Sponsor to arrange multiple training sessions hosted by the

Sponsor’s Medical Monitor for site staff detailing possible study procedures

• Ability to meet important Sponsor deadlines including first/last patient in

• Distribution, compilation, and completion of over 200 site quality controls for a Phase III

Cardiology Study

• Collection and assessment of master site files, documentation of meeting minutes for study team,

and generation of weekly and monthly reports for Sponsor and team members

• In depth therapeutic and protocol knowledge as provided in company training

Myriad Pharmaceutical Inc.

Salt Lake City, UT

Research Associate

2005 – 2007

• Execution of cell-based cytotoxicity/cytoprotection assays for various oncology and infectious disease

studies

• Efficiently interpreted and recorded data and presented research findings weekly at group/project

meetings

• Concurrently worked on various projects with multiple compounds and cell lines

• Responsible for laboratory tasks including ordering supplies, and reagents, maintaining a sterile working

environment, complying with all safe laboratory practices, including those for dealing with infectious

materials (HIV)

Neurocrine Biosciences, Inc.

San Diego, CA

Laboratory Assistant/Intern 2002 – 2004

• Training new interns on various laboratory skills including polymerase chain reaction techniques

for cloning and gene manipulation

• Conducted high throughput DNA sequencing, electrophoresis, plasmid purification, and cell

culture

• Efficiently communicated data with supervisor and group at meetings

Education:

- University of California, San Diego, CA, Introduction to Clinical Research, 2007

- University of California, San Diego, CA, Medical Terminology, 2007

- Utah School of Phlebotomy, Salt Lake City, UT, Certified Phlebotomist, 2005

- University of California, San Diego, CA,

B.S., Pharmacological Chemistry

Minor in Psychology, 2004

Citizenship: U.S Citizen Mobility: Global Language Skills: English: fluent

Hindi: fluent

Spanish: conversational

Professional Associations:

- Association of Clinical Research Professionals

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