SCI - Clinical Trials Regulatory Specialist 2 (Hybrid)

Clinical Trials Regulatory Specialist 2 - Center for Cancer Cell Therapy (Hybrid)

The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Clinical Trials Regulatory Specialist 2 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. This position will support high-impact early phase clinical trials in the CCT group in a variety of cancer indications in both adult and pediatric patient populations. 

The Clinical Trials Regulatory Specialist will work within in multidisciplinary teams of highly skilled physicians, research scientists, cell manufacturing experts, and clinical research staff to conduct innovative early phase clinical trials according to Good Clinical Practice and all relevant institutional, state, and federal policies. We are seeking candidates with excellent communication skills, teamwork, and superb attention to detail.  We strive for top-quality regulatory support of investigator-initiated clinical trials with a high degree of professionalism, initiative and flexibility. No two days are the same, but every day has an impact.

We are looking for someone who already has an interest and established foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies. RAC certification not required, but some previous coursework or prior jobs in regulatory affairs is desired. This position can offer a remote or hybrid work arrangement, including some days onsite and some at home each week.

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 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:

Desired qualifications include a basic understanding of human subjects research regulations, or extensive experience with clinical research in general. Previous experience with CAR-T cells or cellular therapy and/or writing protocols or other scientific writing is desirable. Must be able to work occasionally on site at Stanford’s Palo Alto campus.

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.

CERTIFICATIONS & LICENSES:

None required. RAPS or other regulatory affairs coursework preferred.

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.

* - 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:

Remote and hybrid office work. 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 $102,000 to $118,000 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.