Clinical Trials Regulatory Specialist 2 – 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 Trials Regulatory Specialist 2 in Pediatrics 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 350 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth.  The Clinical Trials Office (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 healthcare in the cancer arena.  

Stanford University is seeking a Clinical rials Regulatory Specialist 2 in Pediatrics to be responsible for the administration and regulatory compliance of clinical research within the university, and representing the university with external regulatory agencies, both domestic and international.

Reporting to the Research Nurse Manager in Pediatric Hematology/Oncology, the Clinical Trials Regulatory Specialist 2 in Pediatrics 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.  

Duties include*:

Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required. Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development. Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.  Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.  Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.  Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees. May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams. May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.  May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation. 

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Experience in Pediatric Hematology/Oncology clinical trials.  Possess strong leadership skills to provide regulatory guidance within disease groups. 

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and five years of related experience or a combination of relevant education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Excellent communication and organizational skills and superb attention to detail.  Experience with MS Office products and database applications required.  Excellent inter-personal skills and customer service focus is required. Experience in clinical research management and oversight, including project management in a dynamic research setting.  Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.  Experience in developing and implementing training/education.  Demonstrated ability to manage multiple projects and staff under varying time constraints. Strong writing 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 sit, 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:

May require occasional local and overnight travel.

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, http://adminguide.stanford.edu.

The expected pay range for this position is $120,551 to $128,895 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.

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.

Additional Information Schedule: Full-time Job Code: 4942 Employee Status: Regular Grade: I Requisition ID: 105875 Work Arrangement : Hybrid Eligible