Clinical Research Coordinator - Midvalley Dermatology

Job Summary

Cook up day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.

Responsibilities

• Create and maintain tools and documentation to track study metrics, providing updates to management.
• Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.
• Maintain source documents and report adverse events.
• Recruit, screen, enroll, and obtain consent from study participants.
• Collect and maintain patient and laboratory data.
• Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies.
• Works under the direction of the Primary Investigator (PI).
• Achie and retain Clinical Research Coordinator Certification (CCRC).
• Understand the process of preparing, submitting, and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
• Prepare regulatory documents, including consent forms for submission to research review committees.
• Communicate with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
• Track study approvals and expirations to ensure uninterrupted project approval.
• Track sponsor and investigator initiated amendment notifications and submit amended protocols, summaries and consents to the Institutional Review Board (IRB).
• Coordinate with study sponsor, investigator and IRB to complete study closure activities.
• Complete time budget assessments and designate study charges vs. standard of care on clinical trials.
• Maintain regulatory database.
• Mentor and train new research staff.

Requirements

• Bachelor's degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required.
• Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.

Qualifications

• Completion of IRB CITI Course or IATA DGR training within a specified timeframe.
• Completion of IRB CITI Course or IATA DGR training within a specified timeframe.
• Nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.

Benefits

The University offers a competitive compensation package and a range of benefits including health insurance, retirement plans, and paid time off.

Pay

$59,000 to $65,000, DOE

Schedule

Monday – Friday