Project Manager Clinical

Nirali Patel

*** ******* ****** ? Jersey City, NJ 07307

Phone: 201-***-**** ? E-mail: *********@*****.***

Objective

Interested in pursuing a career in clinical research which

will allow an opportunity to leverage my knowledge and

experience.

Education Rutgers University, New Brunswick, NJ

July, 2009

Bachelor of Arts in Biological Sciences

Computer Skills

Operating Systems: Windows XP/2000

Software: MS Office Suite, MS Project, Documentum, InForm

4.5 (Clinical EDC System)

Experience

RadPharm Inc.

Princeton, NJ

Project Coordinator

Feb, 2010-Jun,2010

Executed technical and clinical functions as required by

the study protocol and according to RadPharm's Standard

Operating Procedures (SOPs).

Prepared images for QA and reading as directed by study

protocol and Project Manager/Leader.

Responsible for multiple projects and worked both

independently and in a team environment.

Responsible for ensuring clinical trials are conducted

according to all applicable regulations, company procedures

and high ethical/quality standards.

Monitored and tracked clinical trial progress and provided

status update reports

Ensured the timely and appropriate collection, review and

submission of essential documents as required.

Entered, maintained, and tracked data in the computer

database.

Collaborated with management to resolve

technical/radiological/study concerns and problems.

Identified issues and contacted sites and sponsors for

issue resolution.

Reported study needs and issues to the Manager, Clinical

Operations.

Ensured confidentiality of study protocols and subjects.

Amneal Pharmaceuticals Paterson, NJ

Clinical Research Associate Intern May,

2008 - Dec, 2008

Reviewed clinical protocols for completeness and accuracy.

Assisted in developing case report forms in collaboration

with clinical team, ensuring consistency with protocol.

Reviewed clinical data listings for accuracy and generated

queries if required.

Reviewed Case Report Forms for accuracy and completeness.

Responsible for Study File maintenance.

Managed study timelines and provide timely feedback to data

management.

Responded to site issues and recommend corrective actions.

Communicated effectively with internal and external

sources.

Managed the activities of the contract research

organization (CRO) and other vendors.

Familiar with study regulatory requirements and

maintenance.

Related Courses

Genetics: Created genetic experiments using Drosophila

melanogaster and their ability to mate with other flies

producing mutations described by Gregor Mendel and other

famous geneticists.

Microbiology: Conducted ecological testing of different

microorganisms from aquatic and soil environments.

Enrichment and isolation as well as detection and

quantifications of microorganisms from the environment.

Organic Chemistry: Performed a study of nomenclature,

preparations, reactions, and reaction mechanisms of

functional groups of aliphatic and aromatic compounds.

Contact this candidate