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 an SCI Clinical Trials Office (SCI-CTO) Trial Activation Lead 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 SCI-CTO 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 the Director of SCI-CTO Research Services, the Trial Activation Lead will be knowledgeable about the goals, mission, and priorities of the Institute. This understanding will enable the successful execution of the role's responsibilities. The Trial Activation Lead manages key components of cancer clinical research trial activation. This includes overseeing the activation process from start to finish (open to accrual status), which involves interaction with sponsors and Contract Research Organizations (CROs), preparing welcome packets for sponsors, and completing and submitting all necessary documentation for study activation. This process is performed in collaboration with the Principal Investigator, study team members, and other relevant personnel. Additionally, the Trial Activation Lead manages the operational processes and systems that support essential components of clinical study activation within the SCI-CTO. This includes monitoring and managing external data reporting to various parties, such as the National Cancer Institute (NCI) and the Stanford Cancer Institute (SCI) external website. The Trial Activation Lead is also responsible for implementing quality control measures, evaluating and enhancing processes and systems, and collecting and reporting data to internal and external stakeholders.
This is a hybrid position.
Duties include:
- Independently implement, administer and evaluate day-to-day activities of the unit, function or program by identifying and executing tasks and objectives, making recommendations that impact policies and programs, and assigning resources to achieve the goals of the program.
- Collect and analyze data, create reports, review and explain trends; formulate and evaluate alternative solutions and/or recommendations to achieve the goals of the program or function.
- Analyze and interpret policies; develop, revise and implement procedures for program or function.
- Represent the program or function as the key contact and subject matter expert within the department, unit or school. Commit resources and provide information and/or training. May also represent the program or function to external/internal stakeholders and constituencies.
- Organize and/or participate in outreach activities that may include developing communications and training, planning/promoting events and/or conferences.
DESIRED QUALIFICATIONS:
- Master’s Degree Preferred.
- Clinical Research Management or Clinical Trials Design certification.
- Proven experience and extensive expertise in clinical trial activation.
- Ability to understand clinical research study protocol documents.
- Familiarity with common medical terminology.
- Exceptional attention to detail.
- Strong collaboration and communication skills.
- Previous experience with REDCap database and with OnCore or other Clinical Trials Management System (CTMS).
- Data Analytics.
- Microsoft and Google Suite.
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.
PHYSICAL REQUIREMENTS:
- 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.
WORKING CONDITIONS:
- Occasional evening and weekend hours.
WORK STANDARDS:
- 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.
