Specialist Series POOL - Clinical Research Focus jobs in United States
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UC Irvine · 5 months ago

Specialist Series POOL - Clinical Research Focus

UC Irvine is a prominent educational institution seeking candidates for the Specialist Series with a focus on clinical research. The role involves supporting various research activities, including grant preparation, regulatory compliance, and data management throughout the research lifecycle.

Higher Education
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Diversity & Inclusion
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H1B Sponsor Likelynote

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
Assist 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
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
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
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

Qualification

Clinical research coordinationScientific writingProject managementClinical trial designRegulatory complianceData managementStatistical softwareGrant writingCommunicationOrganizational skillsMentoring

Required

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

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

Company

UC Irvine

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UC Irvine

H1B Sponsorship

UC Irvine has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (113)
2024 (86)
2023 (99)
2022 (76)
2021 (81)
2020 (79)

Funding

Current Stage
Late Stage

Leadership Team

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Anand Gala
CEO Roundtable Member
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Bob Romney
Chancellor's CEO Roundtable
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