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.

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).

• Bachelor’s degree in Biological Sciences or related field and at least one year in the area of stem cell/cell therapy research
• Experience with industry sponsored and investigator initiated Clinical Trials
• Extensive experience in collaboration with medical and scientific investigators
• Proven ability to understand complex research protocols, including rationales for clinical/laboratory measurements and results; experience educating staff in the research process
• Demonstrated project management skills and setting performance standards.
• 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 collaboration with diverse audiences, including Principal investigators, agencies, university departments and research project staff.
• Work effectively in a team environment.
• Demonstrate conflict resolution skills in conducting all aspects of work.-Be a self-starter.

• 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 in Phase One Clinical Trials
• Experience with and certification completed for IATA and dangerous good shipping
• Strong knowledge of and skill in use of established protocols and ability to identify and help to establish new protocols as indicated
• 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
• Maintain high levels of quality control, reliability, meet deadlines, train research personnel, and project budgets.
• Work effectively in collaboration with diverse audiences, including Principal investigators, agencies, university departments and research project staff.
• Work effectively in a team environment.
• Demonstrate conflict resolution skills in conducting all aspects of work.-Be a self-starter.

• Work independently, with emphasis on the ability to closely follow clinical policies and procedures
• Must be able to meet HIPAA compliance upon hire
• Must have a valid California driver’s license
• 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
• Must be familiar with and comply with specific and detailed safety procedures, such as biosafety and confined entry requirements, radiation safety and biosafety protocols, asbestos removal procedures, specifics of Material Safety Data Sheets, etc.,
• Must be able to appropriately fit and wear personal protective equipment (PPE) such as TB masks, goggles, face shields, gowns, gloves and protective safety equipment such as safety glasses and safety shoes.,
• Must participate in medical monitoring programs, including film badges, cholinesterase tests, bioassay tests, tuberculosis tests, serum tests, etc.,
• Must participate in preventive medical programs, including immunizations, medical surveillance, and physical examinations., Supervisors/Managers: Responsible for preventing accidents, providing required safety training, observing safety standards and general safety requirements, and ensuring their staff complies with relevant health and safety responsibilities and obligations.

At UC Davis, we’re solving life’s most urgent challenges to bring a fuller, healthier, and more resilient world within reach. We grow from every challenge we take on and we don’t just maintain - we improve.

We recognize that creating an inclusive and intellectually vibrant organization means understanding and valuing both our individual differences and our common ground. The most comprehensive solutions come from the most diverse minds and you belong here.

As you consider joining UC Davis, please explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education, and our latest efforts to outgrow the expected.

The University of California is an Equal Opportunity/Affirmative Action Employer 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.