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Form of workStanford University is seeing an individual who can provide leadership and oversight of Clinical research trials activities within the Department of Radiology. Supervise leads of trials start-up activities and regulatory matters and managers of multiple clinical research staff. Develop new operations and tools to assist in improving trial efficiency, trial finance management, clinical translation of diagnostic and therapeutic innovations within the Department of Radiology and collaborate with the School of Medicine and Industry to draw increased interest and investment in Stanford Radiology Clinical Trials. This position manages overall operations of the Department's resources for Clinical Trials and orchestrates interactions of the Department's Clinical Trials operation with the School of Medicine, the Stanford Cancer Center, and, where appropriate, other resources within Schools across the University. In addition, the position works in partnership with the faculty Director of Clinical Trials and Translation to assist in connecting researchers in the Department with appropriate University and outside resources to meet researchers' required needs (e.g. GMP manufacturing facilities) to pursue Translational Research goals as well as developing educational and training opportunities in Translational Research.
Duties include:
- Make decisions regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
- Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.
- Select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
- Provide direction to PI's, Clinical Research Managers on staffing needs, funding and resources in order to meet the needs of individual research efforts and overall research group.
- Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced Clinical Trials operations and Good Clinical Practice (GCP) knowledge.
- Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
- Liaise with senior management ad cross functional areas and schools. Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
- Manage and coordinate assigned multi-site or large-scale Clinical Trials research studies conducted by a supervising principal investigator(s) in support of actives that meet objectives of assigned research protocol(s).
- Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
- Administer the budget, assign resources accordingly and assist with grant budget proposals.
* - Other duties may also be assigned.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated experience leading and managing clinical trial staff.
- Demonstrated experience leading multi-site or large-scale Clinical Trials research.
- Ability to run a high quality clinical research organization, organizing and motivating teams to follow good clinical practice and regulatory requirements, while providing excellent patient care and study conduct.
- Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
- Project management experience in a research environment.
- Strong knowledge of industry standards and/or regulatory requirements.
- Knowledgeable about insurance billing, and the Medicare Coverage Act.
- Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
- Excellent written, verbal, interpersonal, and presentation skills.
PHYSICAL REQUIREMENTS*:
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally stand, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - 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.
WORKING CONDITIONS:
- Occasional local and overnight travel.
WORK STANDARDS:
- Ensure consistency and adherence to clinical research guidelines, compliance with good clinical practices, good manufacturing practices and regulatory guidelines.
- 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.
The expected pay range for this position is $152,000 to $171,000 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 (https://cardinalatwork.stanford.edu/benefits-rewards) 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.
- Schedule: Full-time
- Job Code: 4937
- Employee Status: Regular
- Grade: L
- Requisition ID: 101705
- Work Arrangement : Hybrid Eligible
