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Clinical Research Quality Assurance
* Personal qualities and interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
* Effectively communicate both orally and in writing. Able to effectively present information.
* Demonstrates leadership ability, accepts responsibility, exercises authority, and functions independently using effective written and verbal communications
* Detail oriented and teamwork skills
* Motivated, organized, able to perform multiple tasks in a timely manner, and work efficiently under pressure. Ability to self-monitor progress and complete assigned tasks independently.
* Ability to manage multiple duties and function independently
* Critical thinker with perceptual and analytical approach to problem solving
* Able to perform diverse clerical duties
* Working knowledge of Microsoft Office applications of Word, Excel, PowerPoint, Outlook, and Internet knowledge skills
* Knowledge of audit processes and monitoring procedures (preferred)
* Minimum 1- 5 years clinical research experience
* Bachelor's degree in nursing or health related field (non-nursing applicants)
* Minimum 3-5 years clinical trials monitoring/auditing in a pharmaceutical company or CRO (preferred)
* Master Degree in health related field (preferred)
* Reviews quality assurance standards, studies existing policies and procedures, and interviews personnel and customers (industry representatives) to evaluate effectiveness of quality assurance program.
* Writes/revises departmental quality assurance SOPs as required.
* Conducts ongoing review of clinical trial patient research charts and data reporting for compliance with federal regulation, institutional policy and study specific requirements.
* Selects specific trial or study staff for data review. Validates source data and accuracy in reporting.
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