Description

Summary

Under the direction of the Executive Director of the Clinical TrialsOffice (CTO) or their designee, the Regulatory Coordinator independentlyperforms administrative and coordinative work directed toward the design,implementation, evaluation, and review of assigned Tulane Cancer Center (TCC)clinical trials by working closely with Principal Investigators (PI) and otherCTO staff members. The RegulatorySpecialist provides operational support for regulatory compliance and is ableto independently provide regulatory support to the TCC PI and research sitesconducting multiple FDA-regulated or other clinical trials. This position is able to successfully managea workload that includes all trial types and mentor other RegulatoryCoordinators. This classification requires the use of judgment and discretionin performing the assigned duties and responsibilities related to theprojects. The Regulatory Coordinatorworks with the PI and CTO staff with moderate to minimal supervision anddirection.

Required Knowledge, Skills, and Abilities

• Excellent written and verbal communication.
• Excellentcomputer literacy skills, including knowledge of standard office software.
• Knowledgeof IRB submission process and requirements.

Required Education and/or Experience

Bachelor'sdegree and three (3) years of clinical research related experience; or RN withcurrent Louisiana state licensure at the time of hire and three (3) years ofclinical research related experience; orLPN with current Louisiana state licensure at the time of hire and six (6)years of clinical research related experience; or a Master's degree and two (2)years of clinical research related experience

Preferred Qualifications

• Master's degree in Public Health, Business or Social work preferred.
• Two or more years of oncology clinical research coordination/relatedexperience
• Clinical Research Certification (e.g., SOCRA, ACRP, etc.)