Clinical Research Assistant: Start-up & Data Coordination

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

Job summary

UC San Diego Health in San Diego, CA seeks an Assistant Clinical Research Coordinator to support start-up procedures, recruitment, and maintenance of subjects within clinical trials.

You will assist with regulatory compliance, data management, and communication with physicians; help prepare consent documents and study materials; and coordinate with PIs on proposals, reports and manuscripts. Strong organizational skills are essential.

Qualifications

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, and/or an equivalent combination of education and experience.
• Experience performing clinical research duties in a clinical research environment with FDA regulations, NCI policies and Good Clinical Practice guidelines.
• Experience interpreting medical charts and abstracting data for study subject screening.
• Experience in medical assessment, patient interviewing, and interpreting lab procedures and values for protocol management.
• Excellent communication skills and ability to interact with diverse stakeholders.
• Experience creating Informed Consent Documents compliant with HRPP/IRB, FDA regulations, and sponsor requirements.
• Experience preparing study documents such as INDs, applications and renewal submissions.
• Proficiency in Word and Excel for reports and documentation.
• Experience maintaining record management systems and handling heavy workload with deadlines.
• Ability to work independently with sound judgment and escalate when needed.
• Knowledge of HRPP/IRB policies and federal regulations governing human subjects protection.

Responsibilities

• Coordinate start-up procedures, recruitment, screening, enrollment, and maintenance of subjects.
• Assist with regulatory compliance and communicate with physicians.
• Maintain clinical research data and patient medical charts, prepare documents and policies for disease teams.
• Support investigators with proposals, progress reports and manuscripts.
• Perform laboratory and data collection activities, process laboratory specimens, and enter data.
• Ensure compliance with relevant state and federal guidelines.

Skills

Clinical research coordination

FDA regulations

HRPP/IRB policies

Data abstraction

Medical chart interpretation

Informed Consent

Regulatory compliance

Communication skills

Record management

Independent work

Education

Bachelor's degree

Tools

Word

Excel

Job description

UC San Diego Health in San Diego, CA seeks an Assistant Clinical Research Coordinator to support start-up procedures, recruitment, and maintenance of subjects within clinical trials.

You will assist with regulatory compliance, data management, and communication with physicians; help prepare consent documents and study materials; and coordinate with PIs on proposals, reports and manuscripts. Strong organizational skills are essential.