US: Clinical Research Associate

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Date: 02-Oct-2009

Clinical Research Associate Responsible for the design, implementation and monitoring of clinical trials as well as preparation of clinical and regulatory reports.

Responsibilities:

* Participate in the design and writing of protocols, case report forms and informed consent forms for clinical trials * Productive in recruitment and selection of new investigators, contract researchers as well as the organization of the outside vendors * Plan and implement all activities required for conducting and monitoring complex clinical trials and ensure that Good Clinical Practices (GCP) are followed * Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout * Monitor investigator performance and adherence to protocol, and proactively address study issues and enrollment problems, as necessary * Ensure that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group * Contribute to the compilation of integrate medical reports and clinical sections of IDEs and Biological License Applications (BLAs) * Prepare integrate medical reports, Investigational Device Exemptions (IDE), periodic reports

Requirements:

* BS in a scientific or related field * 5-8 years' experience in the pharmaceutical or medical device industry including relevant clinical research experience * Intermediate positions require BS in scientific field and 2-4 years related experience * Knowledge of FDA regulatory requirements is preferred

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/