Ohio XYZ Corp. is a new and growing biotechnology company. The Company is in clinical and preclinical development with several targeted agents for the daignosis and treatment of cancer.

Major Duties and Responsibilities:

Responsibilities include participation in designing, planning, implementation and completion of clinical trials. This position will also take responsibility for assessment, initiation and monitoring of clinical sites. Will assist with the design of data collection tools, and the analysis of clinical data. Work with internal and external associates to ensure compliance with protocols, FDA regulations and overall clinical objectives. Assist with coordination of activities of CROs, laboratories and outside vendors. Participate in IND/NDA/BLA filings and writing reports to the FDA.

Requirements:

Bachelor’s degree in scientific discipline, nursing or pharmacy with a minimum of 4 years experience in clinical research in biotech/pharmaceutical industry (must include experience as a CRA). Current knowledge of FDA regulations and GCPs essential. Experience with protocol development and CRF design required. Demonstrated ability to independently train/manage clinical sites. Knowledge of electronic data capture systems preferred. Must be willing to travel 50%. Experience monitoring oncology clinical trials a plus.

Please refer to posting #AZ00-25 when applying for this position.