Clinical Research Coordinator - Midvalley Dermatology

Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within the study team to achieve objectives, coordinating research procedures, study visits, and follow-up care. This position is patient-sensitive and requires immunization according to CDC standards and hospital policy, with limited exemptions for documented medical contraindications or religious beliefs.

Responsibilities

• 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 under the direction of the Primary Investigator (PI).
• Attain 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).
  • Submit study renewal applications and study progress reports to the 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 databases.
• Mentor and train new research staff.
• Create and maintain tools and documentation to track study metrics, providing updates to management.

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 of professional research experience.
• Completion of University RATS Clinical Certification within one year of hire.
• Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills.
• Knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations; an understanding of research procedures; and the ability to function independently.
• Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
• This position is patient-sensitive and must fulfill all associated vaccination requirements or be approved for an exemption prior to the first day of work.

Preferences

• Clinical Research Certification or eligibility to obtain certification within 6 months of hire.
• Completion of CITI and GCP trainings required upon hire.
• Departments may prefer a nursing degree for this position, which requires two years of related experience and a nationally recognized research compliance certification.

Work Environment

• Nearly Continuously: Office environment, hearing, listening, talking.
• Often: Repetitive hand motion (such as typing), walking, standing, sitting.
• Seldom: Infectious disease exposure, oils (air or skin exposure), bending, reaching overhead.

Pay

$59,000 to $65,000, dependent on experience.

Schedule

Full-time, Monday – Friday.