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Colleen Allen

Colleen Allen

Project Director

The EMMES Corporation

Project Director at The EMMES Corporation

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The EMMES Corporation

Project Director

* Manage Phase I-III single- and multi-center studies

* Conduct pre-study site initiation visits, interim site monitoring visits, and close-out visits

* Develop protocols, informed consent forms, source documents, and other study-specific materials

* Develop project Standard Operating Procedures (SOPs)

* Interview, hire, and supervise data managers/protocol monitors

* Prepare Investigational New Drug applications and submit annual reports and safety reports to the Food and Drug Administration (FDA).

* Design and test electronic case report forms (eCRFs) for an internet-based electronic data capture system

* Develop and implement data quality edit checks

Career medium 04
Career
Career medium 03

Arkios BioDevelopment

Clinical Research Associate

* Provided site management and conducted site initiation visits and interim site monitoring visits for a multi-center vaccine clinical trial.

* Edited and revised informed consent forms, case report forms, and source document worksheets

* Facilitated the relay of information and data between Clinical Research Associates and the Project Manager, as the Lead Clinical Research Associate

* Trained and oriented new Clinical Research Associates

Career

The Johns Hopkins University

MPH

University of Virginia