Clinical Research Analyst 4

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
* UC Davis cares about building a community, which is why we provide resources to enhance diversity, equity and inclusion as well as Employee Resource Groups (ERGs) to support our staff

Physical Demands

• Standing - Frequent 3 to 6 Hours
• Walking - Frequent 3 to 6 Hours
• Sitting - Occasional Up to 3 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 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.

For the University of California's Affirmative Action Policy, please visit: https://policy.ucop.edu/doc/4010393/PPSM-20

For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

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