Quality Assurance Specialist
Quality Assurance Specialist
Job Number: 79686
Job Code: 4121
Job Grade: H
The Stanford Cancer Institute (SCI) is a National Cancer Institute-Designated Cancer Center that seeks to build synergies and collaborations across the Stanford University Campus. SCI faculty researchers are active in translational research with more than 250 cancer related clinical research studies ongoing at any time. The Quality Assurance Program is SCI's centralized resource for monitoring ongoing cancer clinical research studies to ensure the conduct of high quality research that is compliant with local and federal regulations. This program functions under the auspices of the SCI Clinical Research Oversight Group.
This Quality Assurance Specialist position which focuses on the Women's Health Program is responsible to review clinical research study conduct for adherence to the study protocol and local and federal regulations. The Quality Assurance Specialist's efforts contribute to improving the quality and efficiencies of conducting clinical trials in compliance with regulatory, documentation, and eligibility requirements.
- Coordinate the Quality Assurance Program: To include but not limited to ensuring that patients are appropriately consented and registered, patients are eligible and overall compliance to the study protocol, ensuring the confidentiality, security, and accuracy of data.
- Independently perform extensive quality assurance review of study documents, case report forms, and data across multiple complex studies and provide findings to the principal investigator, study teams and Data and Safety Monitoring Committee (DSMC).
- Conduct investigational pharmacy monitoring, review drug or device accountability, tracking records, and clinical research pharmacy processes. Verify that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed.
- Act as a key contact and subject matter expert for answering queries related to internal SOPs, GCP guidelines, and current regulations.
- Works collaboratively with clinical investigators and research staff members to address concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.
- Author monitoring reports, status reports, and other communications.
- Participate in development of guidelines and standard operating procedures, as well as educational materials.
- Participates in meetings, FDA inspection or other group audit preparation activities, and special projects as needed.
- Apply knowledge of federal, state and local regulations regarding the conduct of clinical trials, the informed consent process, and the protection of human research subjects.
- Prior monitoring or auditing experience.
- Prior cancer clinical research management experience.
- Strong knowledge of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and protection of human subjects.
- Experience as a user of Microsoft Office products is required, as is familiarity with database usage and reporting tools.
- Ability to prioritize multiple tasks and activities while employing a high level of accuracy, strong communication, and adept interpersonal skills.
- Ability to work independently with minimal supervision.
- Experience developing and delivering training.
- Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS) or The Society of Clinical Research Associates (SOCRA) preferred.
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.
CERTIFICATIONS & LICENSES:
- 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.
Occasional evening and weekend hours.
WORK STANDARDS (from JDL):
- 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.
Location: School of Medicine, California, United States
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.