Clinical Research Audit Assistant - (US-CA-Berkeley - 94720)

Minimum Education: None
Job Type: Full Time
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Responsibilities : The position will be full-time, 80 hours per pay period for the first 90 days of employment; the position will be part-time, 48 hours per pay period for the remainder of the Limited Term contract.  The Clinical Research Audit Assistant is responsible and accountable for ensuring that all patients enrolled into Children's Oncology Group Clinical Trials at Sutter Memorial Hospital meets the Biology, Therapeutic, and Registry protocol eligibility requirements.The incumbent works closely with the Principal Investigators, Pediatric Hematology Nurses, Senior Clinical Research Associates, patients and their families in ensuring proper documentation of the consenting process.The incumbent is also responsible for ensuring that all COG and the patient charts of other Pharmaceutical company trials remain audit-ready at all times.The incumbent is responsible for scheduling and coordinating monthly internal audits with the Pediatric Oncology PI(s) and the Senior CRA(s).The incumbent is also responsible for ensuring revised protocol consents (in which changes directly affect the patient) are presented to the patient/family and signed off in a timely manner. This is a 3 year/156 week Limited Term position.The position will be full-time, 80 hours per pay period for the first 90 days of employment; the position will be part-time, 48 hours per pay period for the remainder of the Limited Term contract.  

Requirements : Bachelor of Science or Bachelor of Arts degree required. Masters degree preferred Demonstrated abilities to professionally handle public contact, confidential information, and maintain effective work flow systems are required.  Experience in word processing, database software, spreadsheets, data reporting and report writing are required.  Prior experience working in a healthcare setting.  Prior experience demonstrating the ability to prioritize and organize work.  Prior experience ensuring compliance with research regulations is preferred.  Knowledge: Knowledge of oncology terminology, disease process and treatments is preferred.  

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