Pediatric Hematology/Oncology Clinical Research Manager
The Stanford Cancer Institute (SCI) is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country. As a NCI-designated Comprehensive Cancer Center the SCI is a dynamic and stimulating place to work as it maintains the highest level of scientific rigor, institutional support and coordination for the complete range of cancer-related research, including basic, translational, clinical and population-based science. The SCI brings together faculty with cancer-relevant expertise from four Schools and over 30 departments throughout the University. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our cancer center to translate research from the laboratory into the clinical setting. Given the SCI’s mission, breadth, and depth it employs ~275 staff members (inclusive of the CCTO) in a fast-paced environment with tremendous opportunities for our Clinical Research teams.
The Cancer Clinical Trials Office in the Stanford Cancer Institute, in Stanford University’s School of Medicine seeks a Clinical Research Manager to provide leadership and oversight of multiple clinical research projects focused in Pediatric Hematology/Oncology. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health. The Clinical Research Manager will be working in Pediatric Hematology/Oncology. The Clinical Research Manager is responsible for supervising multiple clinical research staff along with managing clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.
- Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
- Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants.
- Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
DESIRED QUALIFICATIONS: Pediatric or Oncology Experience. Master’s Degree in related field.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
- Demonstrated managerial experience; such as two or more years of supervisory experience.
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
* 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.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs. (i.e., On-call time for team, 4-6 weeks per year)
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: 4926
- Employee Status: Regular
- Grade: J
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 84415