The Clinical Research Analyst 4 provides advanced-level clinical research regulatory operations, quality assurance, and portfolio management expertise for the Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine's Clinical Research Unit (CRU), with minimal general supervision. This position supports a high-volume and complex assigned Advanced Lung Disease and related pulmonary clinical research portfolio that includes industry-sponsored, federally funded, and investigator-initiated human-subjects research.
Using advanced-level knowledge and independent judgment, the incumbent assesses clinical research operations, analyzes regulatory and operational risks, standardizes study lifecycle workflows, improves documentation quality, supports internal monitoring readiness, develops and implements corrective and preventive action plans, prepares teams for audits and inspections, and maintains OnCore/eReg regulatory tracking across the assigned portfolio.
The incumbent provides functional guidance and quality oversight to clinical research coordinators and study teams; develops tools and best practices to improve regulatory quality and operational consistency; serves as an expert resource for investigators, supervisors, sponsors/CROs, IRB, ancillary departments, and institutional research partners; and may contribute to related start-up, data quality, coverage analysis, budget, invoicing, payment documentation, and financial tracking activities as operational needs require. #CA-SB
Apply By Date 8/22/2026 by 11:59pmMinimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position - Certification by the Society of Clinical Research Associates (SOCRA-CCRP) or the Association of Clinical Research Professionals (ACRP-CCRC/CCRA/CP), or equivalent, required within 1 year of hire if not already held.
- Bachelor's degree in related area or equivalent experience or training
- Extensive experience in clinical research operations, regulatory coordination, clinical research quality, or human-subjects research administration supporting complex clinical trials or clinical research portfolios.
- Experience independently managing regulatory workflows for clinical research studies, including IRB submissions, protocol amendments, continuing reviews, reportable events, regulatory correspondence, essential document maintenance, and study closeout activities.
- Experience interpreting clinical research protocols, FDA regulations, ICH-GCP guidelines, IRB requirements, sponsor requirements, and institutional policies and applying them to complex study conduct issues.
- Advanced knowledge of clinical research practices and philosophy, FDA regulations, ICH-GCP, IRB requirements, HIPAA, research privacy, sponsor requirements, and institutional policies applicable to human-subjects research.
- Advanced analytical and critical thinking skills to interpret complex protocols, assess regulatory and operational risks, evaluate unusual study conduct or documentation issues, and recommend practical solutions.
- Advanced communication and interpersonal skills to explain complex requirements, advise investigators, supervisors, coordinators, sponsors/CROs, IRB, and institutional partners, and provide functional guidance and training to study teams.
- Advanced organizational and project management skills to work independently, set priorities, manage competing deadlines, maintain accurate regulatory records and trackers, and adapt to changing study, sponsor, institutional, and portfolio needs.
- Proven ability to use and support clinical research systems and software, including electronic medical records, OnCore or other CTMS platforms, eReg/eTMF systems, EDC systems, and spreadsheet/reporting tools.
- Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.
Preferred Qualifications - Human Subjects Protection Training (e.g., CITI) prior to engaging in study activities.
- Current certification in Good Clinical Practice (GCP).
- Institutional certifications and trainings as required, including but not limited to HIPAA, privacy, and information security.
- Must maintain compliance with all additional institutional, regulatory, or sponsor-mandated certifications and training requirements as applicable at UC Davis Health.
- Experience assessing operational or regulatory risk, developing corrective and preventive action plans, and supporting audit, inspection, or monitoring response activities.
- Experience providing functional guidance, training, or regulatory operations support to investigators, supervisors, clinical research coordinators, or cross-functional study teams.
- Experience using clinical research systems and databases, such as electronic medical records, OnCore or other clinical trial management systems, eReg/eTMF or regulatory tracking systems, and electronic data capture systems.
- Ability to support a high-volume clinical research portfolio with multiple active protocols, sponsors/CROs, amendments, monitoring findings, regulatory deadlines, and competing operational priorities.
- Ability to develop or improve regulatory workflows, documentation standards, CAPA tools, audit-readiness processes, training materials, trackers, dashboards, and portfolio management tools.
- Ability to serve as an advanced resource and role model for clinical research staff, maintain effective relationships with faculty and cross-functional partners, exercise discretion with sensitive information, and remain composed and professional when addressing complex or escalated issues.
- Ability to independently comprehend and implement complex clinical research protocols, with careful attention and strict adherence to detail.
- Advanced knowledge of pulmonary and critical care medicine or related disease processes as applied to clinical research.
- Advanced skill using IRB submission portals, OnCore, eReg/eTMF systems, electronic medical records, EDC systems, Microsoft Excel, and shared-document platforms in a remote or hybrid clinical research environment.
Key Responsibilities - 40% - Clinical Research Regulatory Operations and Portfolio Leadership
- 30% - Clinical Operations Risk Assessment, CAPA, and Audit Readiness
- 20% - Regulatory Implementation, Study Team Guidance, and Operational Risk Support
- 10% - CTMS/eReg Tracking, Metrics, Reporting, and Professional Development
Department OverviewThe Division of Pulmonary, Critical Care, and Sleep Medicine is an academic unit within the Department of Internal Medicine at UC Davis Health. The division provides patient care in pulmonary, critical care, and sleep medicine, conducts extensive clinical and translational research in areas such as interstitial lung disease, pulmonary hypertension, critical illness, and sleep disorders, and supports education and training for medical students, residents, fellows, and research staff. The division's research unit includes >20 professional staff who support a broad portfolio of clinical trials and investigator-initiated studies.
POSITION INFORMATION - Salary or Pay Range: $ 8,286.25 - $1 5,513.75
- Salary Frequency: Monthly
- Salary Grade: 108
- UC Job Title: CLIN RSCH ANL 4 RP
- UC Job Code: 005236
- Number of Positions: 1
- Appointment Type: Staff: Career
- Percentage of Time: 100 %
- Shift (Work Schedule): M onday through Friday (8:00-5:00)
- Location: Patient Support Services Bldg (HSP014)
- Union Representation: RP - Research and Public Service Professionals
- Benefits Eligible: Yes
- This position is 100% remote
BenefitsOutstanding 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 by visiting UCnet Benefits Page or Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees .
- High quality and low-cost medical plans to choose from to fit your family's needs
- UC pays for dental and vision coverage for you and your family
- Retirement plans for eligible employees including Pension and other Retirement Saving Plans
- Supplemental insurance offered including additional life , short/long term disability , pet insurance , legal coverage , accident, critical illness and hospital indemnity
- Pregnancy and Parental Leave , Family & Medical Leave , Adoption Assistance and Pay for Family Care and Bonding for eligible employees
- Lactation Support Program and Family Care discounts and resources
- Employee Well-being resources and programming to support thriving in all aspects of employee's lives
- On-site Employee Assistance Program including access to free mental health services
- Generous amount of paid Holidays annually as outlined in the UC Policies or Collective Bargaining Agreements
- Paid Time Off/Vacation/Sick Time as outlined in the UC Policies or Collective Bargaining Agreements
- Continuing Education (CE) allowance and Staff Education Reimbursement Program for eligible employees
- Access to free professional development courses and learning opportunities for personal and professional growth
- Public Service Loan Forgiveness (PSLF) Qualified Employer and Student Loan Debt Counseling Program for eligible employees
Physical Demands - Standing - Occasional Up to 3 Hours
- Walking - Occasional Up to 3 Hours
- Sitting - Frequent 3 to 6 Hours
- Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
- Pushing/Pulling 0-25 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
- Reaching overhead - Occasional Up to 3 Hours
- Keyboard use/repetitive motion - Frequent 3 to 6 Hours
Mental Demands - Sustained attention and concentration - Frequent 3 to 6 Hours
- Complex problem solving/reasoning - Occasional Up to 3 Hours
- Ability to organize & prioritize - Frequent 3 to 6 Hours
- Communication skills - Frequent 3 to 6 Hours
- Numerical skills - Occasional Up to 3 Hours
- Constant Interaction - Frequent 3 to 6 Hours
- Customer/Patient Contact - Frequent 3 to 6 Hours
- Multiple Concurrent Tasks - Frequent 3 to 6 Hours
Work EnvironmentUC 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.
Required to work occasional overtime as work demands. Required to travel on occasion for training and educational purposes.
Special Requirements - Please contact your recruiter with questions regarding which activities apply by position - 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.
