Clinical Research Supervisor - Stem Cell Institute - 139303

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 and one (1) Brain Tumor and Neuro-Restoration Program.

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.The incumbent will report directly to the Director of Clinical Research for the CIRM UC San Diego Alpha Clinic and will oversee and manage research protocols for cell and gene clinical trials. The incumbent will coordinate and oversee research start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and community clinics/agencies for the implementation of studies.

The Clinical Research Supervisor will work closely with Principal Investigators to analyze scientific data and propose new clinical protocols. The incumbent will oversee the development of new clinical protocols; and provide work direction and supervision to clinical operations staff. Manage the clinical coordinators including clinical trial implementation and execution, quality and compliance, and strategic planning and project management. The Clinical Research Supervisor will coordinate multiple clinical trials at various stages of development, implementation, and closeout. They will manage the clinical research activities for physicians and supporting research staff working at various UCSD locations, serve as the project director of each protocol, and build a collaborative research team focused on the efficient performance of clinical trials. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction to the team and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Independently create original documents and policies for the team. Work closely with federal and state regulatory officials. Prepare, analyze, and negotiate clinical trial budgets. Make important original contributions and innovative ideas about the strategies and methodologies used in preparing complex scientific clinical research studies. Organize, analyze, and interpret complex, medical, scientific, and technical data and contribute substantively to the development of scientific writing of protocols as well as proposals, including participation in stem cell or gene therapy clinical research, methods, research design, measurement, intervention, and analysis. Additional responsibilities include management and prioritization of queries from Industry Sponsors, Sanford Stem Cell Institute Administration, and individual PIs. Responsible for protocol development and management of phase I, II, and III clinical trials in patients with advanced illness. Participate in research grant opportunities and draft grant proposals as required.

Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.

• Seven years of related experience, education/training, OR a Bachelor's degree in related area plus three years of related experience/training.

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.

• Clear and concise communicator; good verbal and written communication skills; both.

• Strong experience in Clinical Trials and Clinical Trials Program Management. Hands-on experience with Industry sponsored trials, cooperative group trials, and/or investigator initiated trials.

• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.

• Strong knowledge and experience of the clinical research coordinator and regulatory associate roles.

• Demonstrated knowledge of regulatory submissions and compliance.

• Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Demonstrated success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.

• Proven experience managing project budgets including monitoring expenses, creating and analyzing projections, auditing fiscal reports, and providing status reports. Knowledge of accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated ability to successfully create and negotiate clinical trial budgets.

• Critical thinking skills to evaluate issues and identify a potential solution.

• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

• Clinical Trial Professional certification from a professional society within one year in position.

• Knowledge or experience with oncology research and terminology.

• Advanced degree and/or SoCRA or ACRP Certification

• Employment is subject to a criminal background check.