Clinical Research Manager

UC Irvine; California (MO); On-site; USD 90,000 - 150,000; Full time

Job summary

UC Irvine's Center for Clinical Research is seeking a Clinical Research Manager to oversee clinical research operations and staff across CCR locations. The role ensures adherence to study protocols and regulatory standards while managing budgets and vendor relationships.

The CRM will provide strategic guidance, coordinate with investigators, and supervise departments to maintain efficient trial progress. Travel to Irvine campuses may be required to support ongoing studies.

Qualifications

• Experience with study budgets, financial management, and billing oversight.
• Experience in training others in the field of research.
• Excellent verbal and written communication in a scientific environment.
• Ability to maintain confidentiality and interact with diplomacy.

Responsibilities

• Oversee clinical research operations across CCR and multiple sites.
• Lead staffing, onboarding, and workforce optimization.
• Ensure compliance with protocols, SOPs, and regulations.
• Provide high‑level analytical support for strategic initiatives.

Skills

Complex organizational structures

Research design

Study budgets

Personnel management

HR administration

Prioritization

Staff development

Communication skills

Stakeholder management

Regulatory compliance

Project management

FDA, GCP, ICH knowledge

Microsoft Office

Education

Bachelor's degree in related area

Research certification (ACRP, SoCRA, or equivalent)

7+ years of clinical research experience

Experience leading or supervising a team

Tools

Microsoft Office

Job description

Your Role on the Team

Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Clinical Research Manager (CRM) is responsible for all clinical research operational matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise.

Serving as an administrative and operational leader, the Manager oversees multiple Supervisors and their respective specialty units, and is accountable for unit-level operational effectiveness across multiple specialties and clinical locations. The Manager leads staffing models, hiring, onboarding, and workforce optimization, and addresses high-level operational challenges including coverage, call schedules, overtime, and investigator engagement.

The CRM develops and ensures compliance with clinical study protocols that involve human subjects, oversees and resolves operational aspects of clinical studies or trials with project teams in accordance with standard operating procedures, good clinical practice, and regulations. May also be responsible for finances, clinical operations, and site and vendor selection.

The responsibilities are broad and diverse to include personnel management, physician relations, customer service, oversight of study patient screening and enrollment, tracking of clinical trial progress, compliance with regulatory standards, and the general oversight of the research process. Provides high‑level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio.

Required Qualifications

• Demonstrated experience working within complex organizational structures with strict policies and parameters
• Knowledge of research design, research process, study budgets, and study implementation
• Experience with study budgets, financial management, and billing oversight
• Proven track record of personnel management including hiring, performance management, and staff development
• Ability to effectively manage multiple priorities, prioritize projects, and meet the demands of a fast‑paced and dynamic work environment; adaptable to quickly changing priorities
• Demonstrated skills in employee supervision and HR administration
• Demonstrated experience in training others, particularly in the field of research
• Critical thinking skills to evaluate issues and identify a potential solution
• Clear and concise communicator with outstanding verbal and written communication skills
• Good interpersonal skills, including problem‑solving, teamwork development, leadership, mentorship
• Interpersonal skills to effectively motivate others; works well with others to achieve common goals
• Ability to cultivate relationships with multiple stakeholders at various levels of administration
• Effective oral and written communication skills with technical writing skills suitable to compose scientific documents, reports, budgets, and justifications
• Working knowledge of clinical protocol design, content, and categories for inclusion in a final document
• Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy
• Ability to establish and maintain cooperative working relationships with external sponsors, colleagues, faculty, and staff
• Excellent interpersonal, organizational, and time‑management skills
• Ability to work both independently and as part of a team
• Ability to take initiative and demonstrate strong commitment to duties
• Ability to act independently with demonstrated problem‑solving skills, multi‑task, and to follow through on assignments with minimal direction
• Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent
• Ability to analyze complex problems involving long‑range planning, including sources for information and data, and summarizing information into a logical format for presentation
• Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative
• Skill in performing a variety of duties, often changing from one to another with frequent interruptions
• Skill in composing letters, preparing documents, and facilitating the production of materials
• Extensive experience with clinical research and data collection methods
• Ability to work within a deadline‑driven structure
• Experience in maintaining flexibility and adaptability while supervising and implementing institutional change
• Willingness to work as a supportive, cooperative member of an interdisciplinary team
• Foster and promote a positive attitude and professional appearance
• Strong leadership, planning, and project management skills
• Thorough understanding of FDA, GCP, and ICH guidelines
• Thorough understanding of research compliance requirements
• Expertise with Microsoft Office (Word, Excel, Outlook, PowerPoint)
• Access to transportation to off‑site research locations; travel to Irvine campus and satellite work sites as needed
• Bachelor's degree in related area and / or equivalent experience / training
• Research certification (ACRP, SoCRA, or equivalent) required
• A minimum of 7 years of clinical research experience
• Previous experience leading or supervising a team

Preferred Qualifications

• Advanced degree preferred.

Special Conditions

• Some after‑business hours and occasional weekends.

Conditions Of Employment

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment
• 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.
• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Closing Statement

The University of California is an Equal Opportunity Employer. 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 Anti-Discrimination Policy.

We are committed to attracting and retaining a diverse workforce and honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at [phone] or [e-mail].

Must be able to provide proof of work authorization.