Assistant Clinical Research Coordinator - 140861

UC San Diego Internal Recruitment open to UCSD and UCSD Health System Staff Only.

About the Role

The Division of Gastroenterology and Hepatology in the Department of Medicine conducts research studies focused on Metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD) in adult patients. The MASLD Research Center investigates the etiology, contributing factors, natural history, complications, and therapy of MASH and MASLD. The center participates in pharmaceutical clinical trials and Principal Investigator (PI) initiated studies, emphasizing the discovery and validation of innovative biomarkers for MASLD, particularly identifying patients at greatest risk for MASH, advanced liver fibrosis, and hepatocellular carcinoma (HCC).

Under full supervision of the Clinical Research Supervisor, the Assistant Clinical Research Coordinator will coordinate and assist with oversight of start-up procedures, recruitment, screening, enrollment, and maintenance of subjects. Responsibilities include assisting operations, ensuring compliance with state and federal regulatory guidelines, overseeing the quality of medical and clinical research data, and communicating directly with assigned physicians. The role serves as a resource for investigators, assisting with proposals, progress reports, manuscripts, and creating original documents and policies for assigned disease teams. The coordinator will also work closely with federal and state regulatory officials as needed.

At the direction of the Clinical Research Supervisor, the Assistant Clinical Research Coordinator may provide training, data and chart management, quality assurance checks for studies, and backup support for research center activities. Other duties may be assigned as needed.

Responsibilities

• Coordinate and assist with start-up procedures, recruitment, screening, enrollment, and maintenance of study subjects.
• Assist operations and ensure compliance with state and federal regulatory guidelines for clinical research.
• Oversee the quality of medical and clinical research data.
• Communicate directly with assigned physicians and serve as a resource for investigators.
• Assist Principal Investigators (PIs) with proposals, progress reports, and manuscripts.
• Create original documents and policies for assigned disease teams.
• Work closely with federal and state regulatory officials when indicated.
• Provide training, data and chart management, and quality assurance checks for studies.
• Serve as backup for research center activities.
• Perform other duties as assigned.

Requirements

• Theoretical knowledge of biology, microbiology, social sciences, or clinical sciences, typically attained by a Bachelor’s degree, or an equivalent combination of education and experience.
• Experience with laboratory procedures and interpreting laboratory values to determine patient eligibility and potential toxicities.
• Experience interpreting medical charts and abstracting data from medical records.
• Experience with clinical trials participant or study subject recruitment.
• Experience conducting outreach to external clinics for educational and recruitment efforts.
• Experience providing in-service training to research personnel on protocols, processes, and procedures.
• Experience performing clinical research duties in a clinical research environment.
• Proficiency with statistical software applications and database, word processing, and spreadsheet applications (e.g., Velos, Access, Excel, MS Word).
• Experience working with FDA policies regulating clinical trials.
• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
• 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 coordinating study startup activities.
• Knowledge of x-rays, scans, and other diagnostic procedures.
• Experience maintaining files and keeping records.
• Excellent planning, organizational, and prioritization skills to manage a large volume of work in a dynamic environment.
• Strong interpersonal, written, and verbal communication skills, including grammatically correct written English and accurate typing.
• Excellent phone etiquette and ability to interact with a diverse population.
• Ability to work independently and 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.

Preferred Qualifications

• Certification as a Clinical Research Associate or Coordinator.
• Experience working with research bulk accounts.
• Experience with investigational drug authorization criteria.
• Ability to speak Spanish.
• Knowledge of MASLD research studies.

Special Conditions

• Occasional evenings and weekends may be required.
• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.
• Complies with all policies and standards, including the University of California, San Diego Health (UCSDH) Principles of Community.

Pay

Annual Full Pay Range: $75,815 - $121,960 (prorated if the appointment percentage is less than 100%). Hourly Equivalent: $36.31 - $58.41. Factors determining compensation include experience, skills, knowledge, abilities, education, licensure, certifications, and business/organizational needs. The Hiring Pay Scale is $36.31 - $47.36/hour.

Schedule

Full-time (100% appointment), Monday through Friday, 8 hours per day.