Specialist Series POOL - Clinical Research Focus

Specialist Series POOL – Clinical Research Focus Salary range: A reasonable estimate for this position is $55,000–$194,800 for full time, exempt. See table for Specialist Series – Represented Fiscal Year. Application Window: Most recent review date: Monday, Nov 24, 2025 at 11:59pm (Pacific Time). Final date: Saturday, Aug 8, 2026 at 11:59pm (Pacific Time). Applications will be accepted until this final date; those received after the review date will only be considered if the position has not yet been filled. 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 BA/BS, Masters, PhD or MD/PhD degree by the proposed start date. Junior Specialists – Baccalaureate degree (or equivalent research experience). Assistant Specialists – Master’s degree (or equivalent) or five years of related experience. Associate Specialists – Master’s degree (or equivalent) or five to ten years of related experience, plus record of academic accomplishments and public service. Full Specialists – Terminal degree (or equivalent) or ten or more years of related experience, plus significant record of academic accomplishments, professional recognition, and public service. Preferred Qualifications Baccalaureate degree or higher in clinical research, epidemiology, public health, biostatistics, or related field. Certification in clinical research (Certified Clinical Research Professional; Certified Clinical Research Coordinator) or equivalent. 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. Publication record in peer‑reviewed journals, preferably in orthopaedics or musculoskeletal research. 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 for federal, state, and private funding agencies. Conduct comprehensive literature reviews and preliminary data syntheses. Assist in study design, statistical planning, and associated budget planning. Coordinate multi‑site collaboration agreements and regulatory submissions. Study Implementation & Management 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. Coordinate 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 study lifecycle. Dissemination & Publication Manuscript preparation and submission to peer‑reviewed journals. Develop presentation materials for national and international conferences. Coordinate abstract submissions and poster/oral presentations. Contribute to grant progress reports and final study reports. Additional Responsibilities 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. Application Requirements Document requirements Curriculum Vitae – most recently updated CV. Cover Letter. Statement of Research. Reference requirements 3 references (contact information only). Apply link: Equal Opportunity Employer 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. As a condition of employment, finalists will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct. As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements. Job Location Irvine, CA #J-18808-Ljbffr University of California - Irvine