Studies Associate - Pharmaceutical

Responsible for monitoring the Investigator Initiated Research Information System (IIRIS) database for new study submissions and study updates and communicating any important details to the ISS Specialist/Manager and the ISS Review Team as necessary.
Responsible for maintaining study files, including verifying that all required information is current and present in the files.
Responsible for scheduling review meetings, creating the agenda and preparing review materials for distribution to Review Team.
Assists in compiling and documenting ISS review meeting minutes and/or comments.
Responsible for preparing and distributing Investigator correspondence, e.g., approval and rejection letters.
Responsible for preparing, securing signatures/execution and issuing of Confidentiality Agreements, Study Agreements and Amendments (may vary according to TA).
Responsible for obtaining and issuing Investigator Brochures and/or package inserts for Investigators.
Assists in collection of regulatory documents.
Responsible for preparing and issuing the sign off sheets to the Clinical Science Director for all ISSs recommended for approval by the ISS Review Team.
Responsible for managing, and distributing as necessary, the publications received from Investigators.
Responsible for managing the Investigator payment process utilizing ezBuy.
Responsible for archiving ISS files.
Responsible for participating in Functional Area or Brand Team special projects as requested.

Three years administrative or project coordination experience.
Experience working in a team base organization.

Skills:
Strong time management skills
Flexibility to meet multiple demands and changing priorities.
Strong organizational skills.
Demonstrated ability to work independently with meticulous attention to detail.
Excellent computer skills; ability to work in a Windows-based environment; ability to work with multiple databases/computer programs; ability to work with SAP.
Excellent communication and interpersonal skills.
Ability to effectively work in a cross-functional team environment.

Preferred Background:
Bachelor’s degree or equivalent experience.
Pharmaceutical or healthcare industry experience.
Understanding of the drug development process.
Basic understanding of medical terminology.

Please refer to job code stdpharm101409 when responding to this ad.

Category:	Biotech/Pharmaceutical
Location:	Wilmington, DE
County:	New Castle County
ZIP Code:	19801
Pay Rate:	doe
Job Terms:	over 1 year (contract)
Company:	PSCI
Phone:	302-334-4121
Fax:	302-479-7573