Clinical Research Quality Auditor (Administrative Services Administrator 1)
Job Number: 73289
Stanford University is seeking two Quality Auditors to co-develop and coordinate, with CRQ leadership, a Quality Improvement Program within the office of Clinical Research Quality. Develop risk-based audit strategies and selection processes, including statistical methods. Identify priorities for training and standardization of procedures, based on audit outcomes. Write standardized audit plans that can be customized for specific studies or program areas.
The Clinical Research Quality office facilitates clinical research regulatory compliance by developing policies and best practices with the School of Medicine; tracking FDA, GCP, and ClincalTrials.gov compliance; educating and training researchers, both faculty, trainees, and staff; conducting quality reviews and assisting with corrective and preventive action when needed. CRQ collaborates with Stanford University and School of Medicine research compliance and internal audit offices.
Spectrum, the Stanford Center for Clinical and Translational Research and Education, is an interdisciplinary center that facilitates health research across the university. Its core mission is to accelerate the translation of basic scientific discoveries into practical solutions that improve human health, through educational programs, research support, infrastructure streamlining and innovation funding. Spectrum is a member of the Clinical and Translational Science Award (CTSA) consortium, funded by the NIH National Center for Advancing Translational Sciences.
- Independently audit clinical research protocols to identify issues of protocol adherence and regulatory compliance. Preparations will include reviewing protocol documents in order to create an audit plan, selecting subject case files to be audited, and reviewing source documentation (which may include medical records). Collect data and backup documents to determine if the research team is complying with the protocol and regulatory requirements.
- Author audit reports, status reports, and other communications. Participate in the development and dissemination of written communications, such as guidelines and standard operating procedures, as well as educational presentation materials. Some reports and communications may be provided to department or program administration, in addition to investigators, with recommendations for reporting to the Stanford Institutional Review Board, external sponsors or FDA, when needed.
- Establish and maintain an organizational and operational structure for tracking a large amount of information. Regulatory compliance is in flux nationally. This position requires a sound knowledge of federal, state and local regulations regarding the conduct of clinical trials, the informed consent process, and the protection of human research subjects. Will provide guidance to Sponsor-Investigators to help ensure that the additional responsibilities of holding an IND or IDE are met. Also required are: excellent organizational skills and superb attention to detail; strong communication and interpersonal skills as information will be communicated in electronic, written, and verbal communications to principal investigators, medical and research personnel
- Work as part of the CRQ and Spectrum team. Auditors may also at times perform other duties such training research teams in self-auditing techniques and preparing for FDA audits, assisting with external audit preparation, and presenting at educational meetings.
*-Other duties may also be assigned
- A Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- At least 3 years in clinical research in industry or academia.
- Proven auditing ability.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated ability to prioritize own work and multi-task.
- Demonstrated excellent organizational skills.
- Demonstrated ability to take initiative and ownership of projects.
- Ability to communicate effectively both orally and in writing.
- Ability to routinely and independently exercise sound judgment in making decisions.
- Demonstrated experience working independently and as part of a team.
- Relevant subject matter knowledge.
- Ability to direct the work of others, for jobs requiring supervision.
- Constantly perform desk-based computer tasks.
- Frequently stand/walk, sitting, grasp lightly/fine manipulation.
- Occasionally use a telephone.
- Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.WORKING CONDITIONS:
Occasional evening and weekend hours.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
School of Medicine Schedule:
Full-time Classification Level: To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Copyright ©2015 Jobelephant.com Inc. All rights reserved.
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