Specialist Series POOL - Clinical Research Focus

About the role

The Department of Orthopaedics, University of California Irvine Health System, anticipates openings in the Specialist Series (Junior, Assistant, Associate, and Full Specialist) with a focus on supporting clinical research activities spanning the complete research lifecycle including grant preparation, submission, and management; regulatory compliance; data collection, management, and analysis; and manuscript preparation and submission.

Responsibilities

• Collaborate with faculty investigators to develop competitive grant proposals for federal, state, and private funding agencies
• Conduct comprehensive literature reviews and preliminary data syntheses
• Aid in study design, statistical planning, and associated budget planning
• Coordinate multi-site collaboration agreements and regulatory submissions
• Lead protocol development, IRB submissions, and regulatory compliance (FDA, GCP)
• Manage clinical trial operations including patient recruitment, enrollment, and retention
• Oversee or participate in data collection, quality assurance, and database management
• Liaise with clinical staff, research coordinators, and external collaborators
• Ensure adherence to study timelines, budgets, and regulatory requirements
• Support study close-out activities including database lock and final data queries
• Prepare clean datasets and documentation for statistical analysis
• Collaborate with statisticians to ensure proper data interpretation and analysis planning
• Generate interim reports, safety monitoring reports, and final study reports
• Maintain data integrity and implement quality control measures throughout the study lifecycle
• Disseminate and publish research findings
• Prepare and submit manuscripts to peer-reviewed journals
• Develop and present research findings at national and international conferences
• Contribute to grant progress reports and final study reports
• Mentor junior research staff and trainees
• Participate in departmental research seminars and journal clubs
• Contribute to departmental strategic research planning
• Maintain current knowledge of orthopaedic research trends and methodologies

Qualifications

• Baccalaureate degree or higher in clinical research, epidemiology, public health, biostatistics, or related field
• Baccalaureate degree or equivalent research experience for Junior Specialists
• Master’s degree (or equivalent degree) or five years of experience demonstrating expertise in the relevant specialization for Assistant Specialists
• Master’s degree (or equivalent degree) or five to ten years of experience demonstrating expertise in the relevant specialization for Associate Specialists
• Ten or more years of experience demonstrating expertise in the relevant specialization for Full Specialists

Preferred Qualifications

• Professional recognition in the field
• Contributions to published or in-press research in the field
• Demonstrated record of University and/or public service
• Experience with clinical trial design and / or conduct
• Proficiency in research databases (REDCap, etc.), spreadsheets, and / or statistical software (R, SAS, SPSS)
• Knowledge of regulatory requirements (ICH-GCP, FDA regulations, IRB processes)
• Experience with grant writing and funding acquisition
• Publishation record in peer-reviewed journals, preferably in orthopaedics or musculoskeletal research
• Strong project management and organizational skills
• Excellent written and oral communication skills

Application Requirements

• Curriculum Vitae - Your most recently updated C.V.
• Cover Letter
• Statement of Research
• References (contact information only)

About UC Irvine

The University of California, Irvine 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.