DESCRIPTION

In 2022, businessman and philanthropist T. Denny Sanford committed $150 million to the creation of the Sanford Stem Cell Institute at UC San Diego. This gift combines current infrastructure with new Centers intended to leverage the advantages of space-based science, including expansion and, in some ways, quite literally launch stem cell research and regenerative medicine at UC San Diego into new spaces, endeavors, and training of future stem cell scientists.

Sanford Stem Cell Institute provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, daily Sanford Stem Cell Institute personnel work with all 9 Vice Chancellor areas: Academic Affairs; Research Affairs; Equality, Diversity, and Inclusion; Student Affairs; Marine Sciences; Health Sciences; Health System; Chief Financial Officer; Advancement; Resource Management and Planning.

As part of UC San Diego, Sanford Stem Cell Institute motivates University-wide change, sustainability, and partnership, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed.

The new UC San Diego Sanford Stem Cell Institute builds upon a $100 million gift in 2013 from T. Denny Sanford that established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells - special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases.

The new UC San Diego Sanford Stem Cell Institute includes six (6) stem cell Centers led by Center Directors and Deputy Directors.

1. Sanford Integrated Space Stem Cell Orbital Research (ISSCOR) Center, for stem cell research that will be conducted in a laboratory bay located aboard the International Space Station currently in low-Earth orbit.

2. Sanford Stem Cell Fitness and Space Medicine Center, which conducts in-depth space fitness and orbital medicine that can benefit both astronauts and people living on Earth.

3. Sanford Stem Cell Innovation Center, which will support regenerative medicine company development, including contract research in low-Earth orbit.

4. Sanford Stem Cell Discovery Center, which conducts basic and translational stem cell research.

5. Sanford Advanced Therapy Center, which provides fundamental tools and services to move basic research findings to next stages, such as early phase trials.

6. Sanford Stem Cell Clinical Center, which conducts research to accelerate relevant drug and therapy development in regenerative medicine, including clinical trials.

Under general supervision, the Regulatory Coordinator provides regulatory support and project management for product development activities related to the current and pipeline clinical studies of the Sanford Stem Cell Clinical Center's clinical research unit. The incumbent interacts with departments/agencies involved in clinical research including HRPP, OCTA, FDA, Research Compliance, and other regulatory agencies pertinent to clinical research with an emphasis on human subject protection, subject consents, and diverse IRB policies applicable for Sanford Stem Cell Clinical Center members. The incumbent works closely with various functional areas and study teams in developing regulatory strategies, facilitating communications with regulatory agencies, and preparing and submitting regulatory documentation.

MINIMUM QUALIFICATIONS

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Strong knowledge of investigational protocols (various trial products, phases and protocol designs).

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Demonstrated experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents.

• Knowledge of evolving US regulations, guidelines, and specifications applicable to clinical research. Experience interpreting regulations, guidelines, and precedents related to drugs and biologics development.

• Working knowledge of medical and scientific terminology.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Demonstrated ability to work with a diverse group of researchers, administrators, health care professionals and industry.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Computer proficiency, including working knowledge of various software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, VELOS, REDCap, etc.) and internet browser applications. Experience in conducting searches on the internet. Ability and willingness to learn new software as needed.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

PREFERRED QUALIFICATIONS

• Experience in Phase 1 clinical trials.

• Masters Degree in a related field.

• Knowledge of tissue, cellular and gene therapy.

• Direct experience in U.S. regulatory affairs involving the FDA. Knowledge of foreign regulatory requirement is a plus.

• Clinical Research Coordinator certification such as SOCRA or PMP certification.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check and pre-employment physical.

• Pre-employment physical and TB test required.

• Occasional evenings and weekends may be required.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego is an Equal Opportunity/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, age or protected veteran status.

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UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

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