Clinical Research Quality Monitor
The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Quality Monitor to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.
Reporting to PRMS Manager, the Clinical Research Quality Monitor will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to conduct clinical trials monitoring, facilitate discussions to identify corrective and preventative actions when needed and identify and actively participate in trainings and education as needed. We are seeking candidates with excellent skills in communication, critical thinking and having a collaborative outlook Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include monitoring and audits, facilitating discussion among investigators and study teams on process improvement based on monitoring findings and act as a key contact and subject matter expert for answering queries related to internal SOPs, GCP guidelines, and current regulations.
- Independently perform extensive quality assurance review of study documents, case report forms, and data across multiple complex studies to ensure subject safety and research validity. Provide findings to the principal investigator, study teams and Data and Safety Monitoring Committee (DSMC).
- Conduct investigational pharmacy monitoring including review of 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 queries related to internal standard operating procedures, Good Clinical Practice 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.
* - Other duties may also be assigned.
- Prior monitoring or auditing experience in clinical research
- 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.
- 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.
- 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.
- Schedule: Full-time
- Job Code: 4121
- Employee Status: Regular
- Grade: H
- Requisition ID: 88005