Assistant Clinical Research Coordinator - 140861

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

About the Role

As the largest and oldest department within the UC San Diego School of Medicine, the Department of Medicine employs nearly 500 faculty members and 1,000 academic appointees, residents, fellows, postdocs, and staff, in pursuit of its academic, clinical, and research missions. 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 studies the etiology, contributing factors, natural history, complications, and therapy of MASH and MASLD.

The MASLD Research Center participates in pharmaceutical clinical trials and Principal Investigator (PI) initiated studies focused on the discovery and validation of innovative biomarkers for MASLD, with a special emphasis on 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. They will assist operations, ensure compliance with state and federal regulatory guidelines, and help oversee the quality of medical and clinical research data. The role involves direct communication with assigned physicians and serving as a resource to investigators for interpreting, educating, and informing about ongoing clinical trials. Additional responsibilities include assisting PIs with proposals, progress reports, and manuscripts, creating original documents and policies for assigned disease teams, and working with federal and state regulatory officials when necessary.

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.
• Oversee the quality of medical and clinical research data.
• Communicate directly with assigned physicians and serve as a resource for investigators regarding ongoing clinical trials.
• 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.
• Provide backup support for research center activities.
• Interpret medical charts and abstract data from medical records to determine patient eligibility and potential toxicities.
• Perform clinical research duties in a clinical research environment, including recruitment efforts at external clinics.
• Provide in-service training to research personnel on protocols, processes, and procedures.
• Use statistical software applications and maintain knowledge of database, word processing, and spreadsheet applications (e.g., Velos, Access, Excel, MS Word).
• Maintain files and records, ensuring accuracy and confidentiality.
• Complete clinical trials case report forms via hard copy and online.

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 lab 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 recruitment efforts at external clinics.
• Experience providing in-service training to research personnel on protocols, processes, and procedures.
• 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 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 Research 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 changing, multiple-demand setting.
• Strong interpersonal, written, and verbal communication skills, including grammatically correct written English and accurate typing.
• Excellent phone etiquette skills.
• Ability to work independently and maintain confidentiality.
• 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. Hiring Pay Scale: $36.31 - $47.36 per hour.

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.

Schedule

• Days, 8 hours per day, Monday through Friday.
• Full-time position at 100% appointment.