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Cell & Gene Therapy Specialist (CLIN RSCH ANL 4) - SOM: MED:STEM CELL RESEARCH PROGRAM - Sacramento Campus

University of California - Davis
United States, California, Sacramento
December 10, 2022

The UC Davis Alpha Stem Cell Clinic specializes in early phase, first-in-human trials. The Alpha Stem Cell Clinic is devoted to accelerating the translation of all types of stem cell research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel stem cell clinical trials and ancillary studies for a range of difficult diseases. The Alpha Stem Cell Clinic is a wide-ranging collaboration with unique contributions launched by CIRM through the Alpha Clinic and other grants.
Job Summary
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UCD Inst for Regenerative Cure
Union Representation
Benefits Eligible
We offer exceptional employment benefits including medical, dental, and vision plans, generous paid vacations and holidays, excellent retirement savings and investment plans, continuing education, and reduced fee and scholarship programs.
Under general direction of the Program Director and Clinical Operations Manager, the Clinical Research Analyst 4 or Cell and Gene Therapy Specialist is a professional and technical leader that will oversee compliance with clinical study protocols, resolve operational aspects of clinical studies/trials, comply, and analyze clinical research data and make recommendations that have significant impact to the program at the California Institute for Regenerative Medicine (CIRM) UC Davis Alpha Stem Cell Clinic (ASCC).
This position is responsible for all procedural aspects of a wide variety of novel cellular therapy products and devices used in the ASCC including but not limited to receipt, short-term storage, preparation, and transportation of novel products, each requiring special conditions. The individual serves as subject-matter expert in delivery of quality stem cell therapies to the Clinical and Translational Science Center (CTSC) clinic space located in the UCDH Cypress Building, Operating Rooms, Vascular Center, Davis 8, and other UC Davis Health clinical settings. This position serves as a liaison with the community, industry sponsors, and professional groups to help determine the need, relevance, and effectiveness of Alpha Stem Cell Clinic patient care. Develops presentations and trains patient care staff.
Required Qualifications
Applicants are encouraged to upload license and certification if required of the position.
  • Bachelor's degree in Biological Sciences or related field and experience with cell culture, clinical laboratory, or research laboratory.
  • Strong knowledge of and skill in use of established standard operating protocols (SOPs) and ability to identify and help to establish new protocols as indicated
  • Experience in collaboration with medical and scientific investigators
  • Demonstrated project management skills and understanding of performance standards.
  • Experience working with a broad range of professionals, paraprofessionals, the public, and patients.
  • Work experience in a high volume, dynamic, multiple demand clinic, and hospital setting.
  • Excellent written and verbal communication skills in order to deal courteously and effectively with a broad range of professionals, paraprofessionals, the public and patients.
  • Excellent organizational skills in order to rapidly prioritize activities and delegate work in a high volume, dynamic, multiple demand clinic, and hospital setting.
  • Maintain high levels of quality control, reliability, meet deadlines, train research personnel, and project budgets
  • Work effectively in a team environment
  • Demonstrate conflict resolution skills in conducting all aspects of work. Be a self-starter.
Preferred Qualifications
  • 3 years of experience in the field of FDA/IND clinical stem cell procurement and potential stem cell therapies; experience including at least one year in the area of clinical research concentration.
  • Experience with industry sponsored and investigator initiated Clinical Trials
  • Proven ability to understand complex research protocols, including rationales for clinical/laboratory measurements and results; experience educating staff in the research process
  • Proven knowledge of common diagnostic tests, exams, procedures used in stem cell clinical trials including purpose, supplies and/or equipment needed, how to perform test, exam or procedure accurately, infection control mechanisms and accurate recording in medical chart
  • Advanced knowledge of UC Davis clinical care/nursing policies, HIPAA requirements, IRB compliance, JCAHO regulations and federal guidelines for human research procedures
  • Demonstrated knowledge of the Patient Bill of Rights in order to effectively assist patients and assume an advocacy role
  • Experience in Phase One Clinical Trials
Special Requirements
  • Must have a valid California driver's license
  • Work independently, with emphasis on the ability to closely follow clinical policies and procedures
  • Must be able to meet HIPAA compliance upon hire
  • Must be willing to work a flexible schedule based on business needs; position is subject to Medical
  • Surveillance procedures and review in accordance with federal and state laws and regulations and University policy
This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment.
The University of California has implemented a SARS-CoV-2 (COVID-19) Vaccination Program covering all employees. To be compliant with the policy, employees must submit proof of vaccination or a University-approved exception or deferral.
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The advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.