Cell & Gene Therapy Specialist

Job Summary Under general direction of the ASCC Program Director and ASCC Clinical Operations Supervisor, the Clinical Research Analyst 4/Cell and Gene Therapy Specialist is a professional and technical leader who will oversee compliance with clinical study protocols, resolve operational aspects of clinical studies/trials, comply with and analyze clinical research data, and make recommendations that have significant impact on 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, out‑of‑spec FDA approved 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 ASB 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. Minimum Qualifications Required to hold a valid California driver's license, have a driving record that is in accordance with local policies/procedures, and/or enroll in the California Employer Pull Notice Program. Bachelor's degree in Biological Sciences or related field and/or equivalent experience/training. Three (3) years of experience in the field of FDA/IND clinical stem cell procurement and potential stem cell therapies; including at least one (1) year experience in the area of clinical research concentration. Experience with cell culture, clinical laboratory, or research laboratory. Experience in collaboration with medical and scientific investigators. Experience working with a broad range of professionals, paraprofessionals, the public, and patients. Advanced experience and interaction with industry sponsored and investigator initiated Clinical Trials. Demonstrated experience recognizing adverse events and reporting protocols. Advanced experience collaborating with medical and scientific investigators. Advanced knowledge of clinical care/nursing policies, HIPAA requirements, IRB compliance, JCAHO regulations and federal guidelines for human research procedures. 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 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 coordinate work in a high volume, dynamic, multiple demand clinic and hospital setting. Preferred Qualifications Demonstrated experience educating staff in the research process. Experience with Phase One Clinical Trials. Advanced experience and demonstrated ability to conduct study procedures as Patient Care Coordinator of complicated clinical trials. Experience creating and analyzing projections and providing status reports for clinical research programs. 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. Familiarity with surgical nursing, immuno‑compromised patients, working with code teams, and ER procedures. Demonstrated knowledge of the Patient Bill of Rights in order to effectively assist patients and assume an advocacy role. Knowledge of patient education resources at UC Davis Medical Center and in the community. Knowledge of UCD Medical Center clinical and ancillary services. Demonstrates knowledge and understanding of current stem cell clinical trial issues. Key Responsibilities 85% - Program Development and Operations 15% - Outreach and Executive Communication Department Overview 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, cell and gene modification research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel stem cell, cell and gene therapy 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. Benefits High quality and low‑cost medical plans to choose from to fit your family's needs UC pays for Dental and Vision insurance premiums for you and your family Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement Access to free professional development courses and learning opportunities for personal and professional growth WorkLife and Wellness programs and resources On‑site Employee Assistance Program including access to free mental health services Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here Physical Demands Standing - Frequent 3 to 6 Hours Walking - Frequent 3 to 6 Hours Sitting - Continuous 6 to 8+ Hours Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours Lifting/Carrying over 50 lbs - Occasional Up to 3 Hours Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours Bending/Stooping - Occasional Up to 3 Hours Squatting/Kneeling - Occasional Up to 3 Hours Twisting - Occasional Up to 3 HoursClimbing (e.g., stairs or ladders) - Occasional Up to 3 Hours Reaching overhead - Occasional Up to 3 Hours Keyboard use/repetitive motion - Continuous 6 to 8+ Hours Environmental Demands Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours Loud noise levels - Continuous 6 to 8+ Hours Marked changes in humidity or temperature - Frequent 3 to 6 Hours Microwave/Radiation - Occasional Up to 3 Hours Operating motor vehicles and/or equipment - Frequent 3 to 6 Hours Extreme Temperatures - Occasional Up to 3 Hours Uneven Surfaces or Elevations - Frequent 3 to 6 Hours Mental Demands Sustained attention and concentration - Continuous 6 to 8+ Hours Complex problem solving/reasoning - Frequent 3 to 6 Hours Ability to organize & prioritize - Continuous 6 to 8+ Hours Communication skills - Continuous 6 to 8+ Hours Numerical skills - Occasional Up to 3 Hours Constant Interaction - Frequent 3 to 6 Hours Customer/Patient Contact - Continuous 6 to 8+ Hours Multiple Concurrent Tasks - Occasional Up to 3 Hours Work Environment UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e‑cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space. 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. Work independently, with emphasis on the ability to closely follow clinical policies and procedures. Must be able to meet HIPAA compliance upon hire. Special Requirements This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment. This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements. Misconduct Disclosure Requirement As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. A Culture of Opportunity and Belonging At UC Davis, we’re committed to solving life’s most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together. As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. To view the University of California’s Anti-Discrimination Policy, please visit: Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role—or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. To learn more about our background check program, please visit: #J-18808-Ljbffr UC Davis Health