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.
Apply By November 12, 2024
Minimum Qualifications
Bachelor's degree in Biological Sciences or related field and / or equivalent experience / training.
Valid California Driver's License
Three (3) years of experience in the field of FDA/IND clinical stem cell procurement and potential stem cell therapies; experience including at least one (1) year 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.
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.
Demonstrated project management skills and understanding of performance standards.
Ability to work 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
Experience educating staff in the research process.
Experience in Phase One Clinical Trials.
Experience with industry sponsored and investigator initiated Clinical Trials.
Proven ability to understand complex research protocols, including rationales for clinical/laboratory measurements and results.
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.
Key Responsibilities
65% - Program Development and Operations Manager
15% - Outreach and Executive Communication
10% - Staff Oversight and Leadership
10% - Miscellaneous Duties
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 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.
Position Information
Salary or Pay Range: $7,666 - $14,333
Salary Frequency: Monthly
Salary Grade: 24
UC Job Title: CLIN RSCH ANL 4
Number of Positions: 1
Appointment Type: Staff: Career
Percentage of Time: 100%
Shift Hours: 8 hours
Location: UCD Inst for Regenerative Cure (HSP041)
Union Representation: 99 - Non-Represented (PPSM)
Benefits Eligible: Yes
Hybrid/Remote/Onsite: This position is 100% on-site
Benefits
Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.
If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html
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
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 Hours
Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
Reaching overhead - Occasional Up to 3 Hours
Keyboard use/repetitive motion - Occasional Up to 3 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
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
Work independently, with emphasis on the ability to closely follow clinical policies and procedures.
Special Requirements
This is a critical position, as defined by UC policy and local procedures, and as such, employment is contingent upon successful completion of background check(s), including but not limited to criminal record history background check(s)
This is a positions with direct access to or responsibility for controlled substances, high risk hazardous chemicals, biological or radioactive/nuclear materials
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
Diversity, Equity, Inclusion and Belonging
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, Davis is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.
Because we want you to be seen, our recruiting process at UC Davis fosters authenticity, diversity, and inclusion. Studies have shown that some people may not apply to jobs unless they meet every single qualification. Each unique role at UC Davis has a set of requirements and you could be perfect for this role, or you could be perfect for the next role! Don't meet all the requirements? We still encourage you to apply! #YouBelongHere #CA-CC #LI-CC1
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.
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UC Davis is the home of the Aggies — go-getters, change makers and problem solvers who make their mark at one of the top public universities in the United States. Since we first opened in 1908, we’ve been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into our 100-plus-year history and our reputation for solving problems related to food, health, the environment and society.Our 5,300-acre campus is in the city of Davis, a vibrant college town of about 68,000 located in Yolo County. The state capital is 20 minutes away, and world-class destinations such as the San Francisco Bay Area, Lake Tahoe and the Napa Valley are within a two-hour drive.