Clinical Research Supervising Lead

Clinical Research Supervising Lead – Hematology (Hybrid)

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 Supervising Lead (CRC3) to help us enact our mission to reduce cancer mortality through comprehensive 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. 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 Hematology Clinical Research Manager (CRM), the CRC3 will be conversant in the goals, mission, and priorities of the Institute, and utilize this knowledge to ensure the safety and well-being of trial participants. We are seeking candidates with excellent interpersonal skills and attention to detail. 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. This position is based on the Stanford Medicine campus with options for hybrid work.

This position collaborates closely with physician investigators and clinical research staff to drive successful implementation of cancer clinical trials. Responsibilities include working with the research team(s), clinical staff and Stanford Health Care departments to support conduct of safe and compliant clinical research.

Duties include

• Oversee and manage all aspects of clinical trials including industry and investigator-initiated trials.
• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting / recruiting research participants and retaining participants in long-term clinical trials.
• Manage data / oversee data management for research projects. Meet DSMC requirements for site management up to date. Develop and manage systems to organize, collect, report, and monitor data collection. Extract and analyze data.
• Maintain site regulatory file, per CTO guidelines.
• Develop project schedules, keep targets, measurements, and accountabilities, as assigned. Lead team and clinic operations meetings and prepare / approve minutes.
• Formally mentor new staff, as assigned, participate in hiring process, prepare or Assist with the preparation of performance evaluations and performing related duties, in addition to instruction on project work.
• Audit operations to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions / processes. Monitor Institutional Review Board / SRC / DSMC submissions, and respond to requests and questions.
• Collaborate with principal investigators, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies / processes; define best practices.
• Develop study budget with staff and principal investigator, track patient and study specific milestones, review patient billing and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Manage audit preparation of clinical trials at Stanford and subsites. Provide oversight to subsites.
• Work with principal and clinic lead investigators to ensure Institutional Review Board renewals are completed.
• Other duties may also be assigned.

DESIRED QUALIFICATIONS :

EDUCATION & EXPERIENCE (REQUIRED) :

Bachelor's degree in a related field and four years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED) :

CERTIFICATIONS & LICENSES :

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS

WORKING CONDITIONS :

WORK STANDARDS :

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, .

The expected pay range for this position is $109,826 to $123,774 per annum.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.