National Clinical Trials Network Quality and Education Specialist
The Stanford Cancer Institute (SCI) is a National Cancer Institute (NCI) 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 NCI National Clinical Trials Network (NCTN) Program is a very important component of the Stanford Cancer Clinical Research Program, providing important study opportunities for our patients and leadership opportunities for Stanford faculty. The infrastructure support for this program is located in the SCI Cancer Clinical Trials Office.
The NCTN Quality & Education Specialist will focus on building and maintaining quality systems for the NCTN Program, including the following specific responsibilities.
- NCTN Education & Training – The NCTN Quality & Education Specialist is responsible for developing an education curriculum specific to NCTN requirements that complements the existing Cancer Clinical Trials Office (CCTO) education program. The NCTN Quality & Education Specialist will provide the training in collaboration with NCTN program management. In addition, the NCTN Quality & Education Specialist will provide education to NCTN investigators based on the defined investigator curriculum and in response to changes in NCTN requirements.
- NCTN SOPs and Guidelines – The NCTN Quality & Education Specialist will develop and maintain NCTN-specific SOPs and guidelines that are designed to ensure compliance with all NCTN and regulatory requirements.
- CAPA Management – The NCTN Quality & Education Specialist will oversee and manage any active CAPAs by tracking that deliverables are on target and monitoring the effectiveness of the preventative action(s). The NCTN Quality & Education Specialist will be integrally involved in the development of any new CAPAs related to NCTN study conduct.
- NCTN Quality Monitoring – The NCTN Quality & Education Specialist will track ongoing monitoring activities (internal and external) and will review the outcome of those activities to determine any warranted changes to quality systems. As time permits as development of the NCTN quality systems progresses, the NCTN Quality & Education Specialist will be directly involved in quality monitoring activities of NCTN studies.
- NCTN Group Audits – The NCTN Quality & Education Specialist will be the liaison with the NCTN group auditors for scheduling, ensuring submission of required documents, facilitating the audit and following up on audit issues including audit report response.
* - Other duties may also be assigned.
- Experience conducting NCTN clinical studies.
- Experience developing and delivering training.
- Experience developing standard operating procedures and process guidelines
- Experience monitoring or auditing 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.
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 and lift/carry/push/pull objects that weigh up to 10 pounds.
- 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.
- Travel locally and cross-university.
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.