Specialist Series POOL - Clinical Research Focus

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.

The ideal candidates should be self-driven and motivated with demonstrated expertise in clinical research coordination, project management, and/or scientific writing. This is an ongoing recruitment with both part-time (20-40% FTE) and full-time (>80% FTE) positions available. Rank will be determined by qualifications and experience. Renewal is based on availability of extramural funding and research productivity.

Basic Qualifications

Candidates must possess a BA/BS, Masters, PhD or MD/PhD degree by the proposed start date. Junior Specialists should possess a baccalaureate degree or equivalent research experience. Assistant Specialists should possess a master's degree or five years of experience. Associate Specialists should possess a master's degree or five to ten years of experience with a record of academic accomplishments. Full Specialists should possess a terminal degree or ten or more years of experience with a significant record of academic accomplishments.

Preferred Qualifications

• Baccalaureate degree or higher in clinical research, epidemiology, public health, biostatistics, or related field
• Certification in clinical research
• Experience with clinical trial design and conduct
• Proficiency in research databases and statistical software
• Knowledge of regulatory requirements
• Experience with grant writing and funding acquisition
• Publication record in peer-reviewed journals
• Experience with multi-site clinical studies
• Strong project management and organizational skills
• Excellent written and oral communication skills

Description of Responsibilities

Grant Development & Study Start-Up

• Collaborate with faculty investigators to develop competitive grant proposals
• Conduct literature reviews and preliminary data syntheses
• Assist in study design, statistical planning, and budget planning
• Coordinate multi-site collaboration agreements and regulatory submissions

Study Implementation & Management

• Lead protocol development, IRB submissions, and regulatory compliance
• Manage clinical trial operations including patient recruitment and enrollment
• Oversee data collection, quality assurance, and database management
• Liaise with clinical staff and external collaborators
• Ensure adherence to study timelines, budgets, and regulatory requirements

Study Close-out & Data Analysis Support

• Coordinate study close-out activities
• Prepare clean datasets and documentation for statistical analysis
• Collaborate with statisticians
• Generate reports and maintain data integrity

Dissemination & Publication

• Manuscript preparation and submission
• Develop presentation materials
• Coordinate abstract submissions
• Contribute to grant progress reports

Additional Responsibilities

• Mentor junior research staff
• Participate in departmental research seminars
• Contribute to departmental strategic research planning
• Maintain current knowledge of orthopaedic research trends

Application Requirements

• Curriculum Vitae
• Cover Letter
• Statement of Research
• 3 references (contact information only)