Clinical Research Coordinator I

5 days ago

Santa Barbara, California, United States Sansum Diabetes Research Institute Full time
Job Summary

We are seeking a highly skilled Clinical Research Coordinator I to join our team at the Sansum Diabetes Research Institute. The successful candidate will be responsible for coordinating and managing clinical research trials, ensuring the integrity and quality of our research studies.

Key Responsibilities
  • Study Coordination
    • Responsible for the overall quality and integrity of assigned clinical research trials
    • Organize and lead assigned studies, ensuring timely completion and adherence to protocols
  • Communication and Collaboration
    • Communicate effectively with sponsors, site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs)
    • Prepare, schedule, and lead study visits with monitors, sponsors, and auditors
  • Regulatory Compliance
    • Ensure compliance with Good Clinical Practice (GCP) regulations, state and local laws, and study protocols
    • Participate in the Informed Consent process, including drafting, amending, and conducting Informed Consent visits with study subjects
  • Data Management
    • Complete Case Report Forms (CRFs) for assigned studies and enter electronic data as required by the study
    • Ensure CRFs are completed and up-to-date prior to site monitor visits
  • Adverse Event Reporting
    • Complete and submit Adverse Event (AE) forms per protocol and regulatory guidelines
    • Submit Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence
  • Subject Recruitment and Education
    • Supervise the recruitment process for assigned studies, screen potential subjects, and conduct subject visits
    • Establish and maintain relationships with study subjects and provide education on the clinical trial process
  • Regulatory Documents
    • Complete regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals
  • Professional Development
    • Attend Investigator Meetings as assigned
    • Maintain drug and device accountability and dispensing logs for assigned studies
Requirements
  • Education and Experience
    • High school diploma and Bachelor's degree or equivalent experience
    • At least two years of experience working in clinical research
  • Skills and Qualifications
    • Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
    • Knowledge of drug development process, ICH guidelines, and FDA CFRs
    • Ability to lead studies independently and handle multiple studies simultaneously
    • Excellent communication, organizational, and interpersonal skills
Working Conditions

The work environment is generally an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three areas may be required in the execution of the employee's functional activities.

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