Clinical Research Coordinator - 135948

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.

Incumbent will coordinate and oversee 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 agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies as well as lead, direct, and coordinate operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and contribute toward the development policies along with supervisor. Work closely with federal and state regulatory officials

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

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Working knowledge of medical and scientific terminology.

• 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.

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

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

• Strong knowledge of investigational protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Strong experience completing clinical trials case report forms via hard copy and online.

• 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.

• 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 word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

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

• Possess a Clinical Research Coordinator Certificate, or Masters Degree.

• 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.