Clinical Research Coordinator: Start-Up & Compliance

UC San Diego; San Diego (CA); On-site; USD 76,000 - 122,000; Full time

Job summary

UC San Diego is seeking an Assistant Clinical Research Coordinator to support start-up procedures, recruitment, screening, enrollment, and maintenance of subjects in clinical trials. Under supervision, you will assist with regulatory compliance, data management, and communication with investigators and physicians.

You will help prepare documentation for HRPP/IRB, coordinate with PIs, and support proposals, progress reports, and manuscripts.

Qualifications

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, or equivalent.
• Experience performing clinical research duties in a clinical research environment and familiarity with FDA/NCI guidelines and GCP.
• Experience interpreting medical charts and abstracting data from medical records for study screening.
• Experience in medical assessment, patient interviewing, and interpreting lab procedures to determine toxicities and eligibility.
• Excellent written and verbal communication, including accurate typing and professional interaction with diverse stakeholders.
• Experience creating Informed Consent Documents compliant with HRPP/IRB and regulatory requirements.
• Experience preparing regulatory documents (INDs, New Study Applications, Renewals, etc.).
• Proficient in standard word processing and data management software to develop reports.
• Experience maintaining record management systems and handling competing deadlines.

Responsibilities

• Coordinate start-up procedures, recruitment, screening, enrollment, and maintenance of subjects.
• Ensure compliance with state and federal regulations; communicate with physicians and investigators.
• Assist with proposals, progress reports, and manuscripts; develop policies for disease teams.
• Interact with regulatory officials when indicated and ensure regulatory compliance.
• Perform laboratory and data collection activities; process and submit samples.
• Maintain accurate clinical research files and patient medical charts.

Skills

Interpersonal communication

Data interpretation

Medical chart review

Report preparation

Independent work

Policy documentation

Time management

IRB/HIPAA knowledge

Education

Bachelor's degree or equivalent

Tools

Word

Excel

Job description

UC San Diego is seeking an Assistant Clinical Research Coordinator to support start-up procedures, recruitment, screening, enrollment, and maintenance of subjects in clinical trials. Under supervision, you will assist with regulatory compliance, data management, and communication with investigators and physicians.

You will help prepare documentation for HRPP/IRB, coordinate with PIs, and support proposals, progress reports, and manuscripts.