Assistant Clinical Research Coordinator - TP139440

UC San Diego is hiring a temporary Assistant Clinical Research Coordinator to support clinical research studies. The role coordinates study start-up, participant recruitment and enrollment, study operations, regulatory compliance, and research data quality, with additional support for training and study management as needed.

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Responsibilities

• Coordinating start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects
• May create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies
• The Clinical Research Coordinator may plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and help to coordinate operational efforts, assure compliance with state and federal regulatory guidelines, oversee the quality of the medical and clinical research data, provide direction and guidance to investigators, provide education and information to the general public concerning the ongoing clinical trials, assist PIs with proposals, progress reports and manuscripts, independently create original documents and policies for assigned disease teams, work closely with federal and state regulatory officials when/if indicated
• At the direction of the Clinical Research Supervisor, the CRC may: provide training, data and chart management, quality assurance check for studies, provide backup to research center activities
• Other duties assigned as needed

Preferred

• Bilingual English/Spanish
• Experience with EPIC
• Certification as a Clinical Research Associate or Coordinator
• Experience working with research bulk accounts
• Experience with investigational drug authorization criteria
• Knowledge of MASLD research studies

Benefits

• Medical coverage
• Paid vacation and sick time
• Paid holidays
• Training and development opportunities
• Mid-level benefits are available
• 100% on site
• SDSC enables science and engineering discoveries through advances in computational science and data-intensive, high-performance computing.
• La Jolla, California, USA
• http://www.sdsc.edu/
• Growth Stage
• Total Funding
• unknown
• Key Investors
• National Science Foundation
• 2024-12-05
• Grant
• Leadership Team
• Ilkay Altintas, Ph.D.
• Chief Data Science Officer
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Qualifications

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience
• Experience performing clinical research duties in a clinical research environment
• Experience using statistical software applications
• Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word
• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities
• Experience working with FDA policies regulating clinical trials
• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management
• Experience interpreting medical charts, experience in abstracting data from medical records
• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens
• Experience with clinical trials participant or study subject recruitment
• Experience coordinating study startup activities
• Experience providing in-service training to various research personnel on protocols, processes, and procedures
• Knowledge of x-rays, scans, and other diagnostic procedures
• Experience maintaining files and keeping records
• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately
• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population
• Excellent phone etiquette skills
• Ability to work independently
• Ability to maintain confidentiality
• Experience completing clinical trials case report forms via hard copy and online
• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients
• Experience with external clinics for educational and recruitment efforts
• Bilingual English/Spanish
• Experience with EPIC
• Certification as a Clinical Research Associate or Coordinator
• Experience working with research bulk accounts
• Experience with investigational drug authorization criteria
• Knowledge of MASLD research studies

Required skills

• Clinical Laboratory Procedures and Values, Clinical Practice (GCP), Clinical Research Coordination, Clinical Trial Recruitment, FDA Clinical Trial Regulations, Human Research Protection Program (HRPP), Medical Chart Interpretation and Data Abstraction, Microsoft Access, Microsoft Excel, Microsoft Word, Study Startup Coordination, Velos

Preferred skills

• Bilingual English/Spanish, Experience with EPIC, Experience with investigational drug authorization criteria, Experience working with research bulk accounts, Knowledge of MASLD research studies

Experience

• Mid level