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 - Appointees to the Junior rank should possess a baccalaureate degree (or equivalent degree) or equivalent research experience.

Assistant Specialists - Appointees to the Assistant rank should possess a master's degree (or equivalent degree), or five years of experience demonstrating expertise in the relevant specialization.

Associate Specialists - Appointees to the Associate rank should possess a master's degree (or equivalent degree) or five to ten years of experience demonstrating expertise in the relevant specialization. Associate Specialists are normally expected to have a record of academic accomplishments, including contributions to published or in-press research in the field and a demonstrated record of University and/or public service.

Full Specialists - Appointees to the Full rank should possess a terminal degree (or equivalent degree) or ten or more years of experience demonstrating expertise in the relevant specialization. Specialists at full rank are normally expected to have a significant record of academic accomplishments, including contributions to published or in-press research in the field, professional recognition in the field, and a demonstrated record of University and/or 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

Study Close-out & Data Analysis Support

* 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

Candidates must possess a BA/BS, Masters, PhD or MD/PhD degree by the proposed start date.

Junior Specialists - Appointees to the Junior rank should possess a baccalaureate degree (or equivalent degree) or equivalent research experience.

Assistant Specialists - Appointees to the Assistant rank should possess a master's degree (or equivalent degree), or five years of experience demonstrating expertise in the relevant specialization.

Associate Specialists - Appointees to the Associate rank should possess a master's degree (or equivalent degree) or five to ten years of experience demonstrating expertise in the relevant specialization. Associate Specialists are normally expected to have a record of academic accomplishments, including contributions to published or in-press research in the field and a demonstrated record of University and/or public service.

Full Specialists - Appointees to the Full rank should possess a terminal degree (or equivalent degree) or ten or more years of experience demonstrating expertise in the relevant specialization. Specialists at full rank are normally expected to have a significant record of academic accomplishments, including contributions to published or in-press research in the field, professional recognition in the field, and a demonstrated record of University and/or public service.

• 3 required (contact information only)

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, the finalist 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.

• "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy for Employees, Students and Third Parties
• 
  APM - 035: Affirmative Action and Nondiscrimination in Employment.
  
  

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.