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. 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.

Responsibilities

• Assesses clinical research operations, analyzes regulatory and operational risks, standardizes study lifecycle workflows, and improves documentation quality.
• Supports internal monitoring readiness, develops and implements corrective and preventive action (CAPA) plans, and prepares teams for audits and inspections.
• Maintains OnCore/eReg regulatory tracking across the assigned portfolio.
• 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.
• Contributes to related start-up, data quality, coverage analysis, budget, invoicing, payment documentation, and financial tracking activities as operational needs require.
• 40% - Clinical Research Regulatory Operations and Portfolio Leadership: Leads regulatory operations and portfolio management for complex clinical research studies.
• 30% - Clinical Operations Risk Assessment, CAPA, and Audit Readiness: Identifies risks, develops CAPA plans, and ensures audit readiness.
• 20% - Regulatory Implementation, Study Team Guidance, and Operational Risk Support: Implements regulatory requirements and provides guidance to study teams.
• 10% - CTMS/eReg Tracking, Metrics, Reporting, and Professional Development: Manages tracking systems, metrics, and reporting while supporting professional growth.

Requirements

• Bachelor's degree in a related area or equivalent experience/training.
• Extensive experience in clinical research operations, regulatory coordination, clinical research quality, or human-subjects research administration supporting complex clinical trials or 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.
• Experience interpreting clinical research protocols, FDA regulations, ICH-GCP guidelines, IRB requirements, sponsor requirements, and institutional policies.
• Advanced knowledge of clinical research practices, FDA regulations, ICH-GCP, IRB requirements, HIPAA, research privacy, sponsor requirements, and institutional policies applicable to human-subjects research.
• 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.

Skills

• Advanced analytical and critical thinking to interpret complex protocols, assess risks, and recommend solutions.
• Advanced communication and interpersonal skills to advise investigators, sponsors, IRB, and institutional partners.
• Advanced organizational and project management skills to manage competing deadlines and adapt to changing needs.
• Proficiency in clinical research systems (e.g., OnCore, eReg/eTMF, EDC, EMR) and spreadsheet/reporting tools.
• Ability to support high-volume portfolios with multiple protocols, sponsors, and regulatory deadlines.
• Ability to develop workflows, documentation standards, CAPA tools, and training materials.
• Advanced knowledge of pulmonary/critical care medicine or related disease processes as applied to clinical research.
• Skill using IRB portals, OnCore, eReg/eTMF, EMR, EDC, Microsoft Excel, and shared-document platforms.

Preferred Qualifications

• Human Subjects Protection Training (e.g., CITI) prior to engaging in study activities.
• Current certification in Good Clinical Practice (GCP).
• Institutional certifications (e.g., HIPAA, privacy, information security).
• Experience assessing operational/regulatory risk, developing CAPA plans, and supporting audit/inspection responses.
• Experience providing functional guidance or training to investigators, coordinators, or cross-functional teams.
• Ability to develop regulatory workflows, documentation standards, and portfolio management tools.

Benefits

• High-quality, low-cost medical, dental, and vision plans for employees and families.
• Retirement plans, including pension and retirement savings options.
• Supplemental insurance (e.g., life, disability, pet, legal, accident, critical illness).
• Pregnancy and parental leave, family & medical leave, adoption assistance, and pay for family care/bonding.
• Lactation support program and family care discounts.
• Employee well-being resources and free mental health services via Employee Assistance Program.
• Paid holidays, vacation, and sick time as outlined in UC policies.
• Continuing education allowance and staff education reimbursement program.
• Access to free professional development courses and learning opportunities.
• Public Service Loan Forgiveness (PSLF) eligibility and student loan debt counseling.

Pay

$8,286.25 - $15,513.75 per month.

Schedule

• Monday through Friday, 8:00 AM – 5:00 PM.
• 100% remote position.
• Occasional overtime and travel for training/education may be required.

Physical Demands

• Standing: Occasional, up to 3 hours.
• Walking: Occasional, up to 3 hours.
• Sitting: Frequent, 3 to 6 hours.
• Lifting/Carrying: Occasional, 0-25 lbs.
• Pushing/Pulling: Occasional, 0-25 lbs.
• Bending/Stooping/Squatting/Kneeling/Twisting/Reaching: Occasional, up to 3 hours.
• Keyboard Use/Repetitive Motion: Frequent, 3 to 6 hours.

Mental Demands

• Sustained Attention/Concentration: Frequent, 3 to 6 hours.
• Complex Problem Solving/Reasoning: Occasional, up to 3 hours.
• Organizing & Prioritizing: Frequent, 3 to 6 hours.
• Communication Skills: Frequent, 3 to 6 hours.
• Numerical Skills: Occasional, up to 3 hours.
• Interaction/Customer Contact: Frequent, 3 to 6 hours.
• Multiple Concurrent Tasks: Frequent, 3 to 6 hours.

UC Davis is a smoke and tobacco-free campus. Employment is contingent upon clearing a criminal background check, drug screening, and compliance with mandated reporter (CANRA) and misconduct disclosure requirements.