Clinical Research Coordinator: Trials Start-Up & Compliance

University of California - San Diego Medical Centers; San Diego (CA); On-site; USD 76,000 - 122,000; Full time

Job summary

University of California - San Diego Medical Centers seeks an Assistant Clinical Research Coordinator to coordinate start-up, recruitment, enrollment, and maintenance of clinical study subjects under supervision. You will ensure regulatory compliance, manage data and communicate with PIs and physicians throughout the trial lifecycle.

The role requires familiarity with FDA regulations, GCP, HRPP/IRB policies, and experience in medical record abstraction and data management.

Qualifications

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or a Bachelor's degree, and/or an equivalent combination of education and experience.
• Experience performing clinical research duties in a clinical research environment with FDA/NCI guidelines and GCP.
• Experience interpreting medical charts and abstracting data from records for subject screening.
• Experience in medical assessment, patient interviewing, and interpreting lab procedures and values for protocol management.
• Excellent written and spoken English with ability to interact across levels of the organization.

Responsibilities

• Coordinate and assist with start-up procedures, recruitment, screening, enrollment, and maintenance of subjects under supervision.
• Assist operations, ensure compliance with state and federal regulatory guidelines, and maintain clinical research data.
• Communicate with assigned physicians and assist PIs with proposals, progress reports, and manuscripts.
• Prepare and edit documents such as Investigational Drug Fact Sheets, New Study Applications, Renewal Applications, INDs, etc.

Skills

Regulatory compliance

IRB/HRPP familiarity

Data management

Medical chart abstraction

Communication skills

Informed Consent documents

Documentation and reporting

Education

Bachelor's degree or equivalent

Tools

Word

Excel

Job description

University of California - San Diego Medical Centers seeks an Assistant Clinical Research Coordinator to coordinate start-up, recruitment, enrollment, and maintenance of clinical study subjects under supervision. You will ensure regulatory compliance, manage data and communicate with PIs and physicians throughout the trial lifecycle.

The role requires familiarity with FDA regulations, GCP, HRPP/IRB policies, and experience in medical record abstraction and data management.