GENERAL SUMMARY

The Clinical Research Coordinator II of Cancer Clinical Research Office (CCRO) is an integral member of the research team. The Clinical Research Coordinator works independently to support the Principal Investigator by providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board

(IRB). Ensures the data quality and integrity for each clinical trial and communication with the Principal investigator, Manager and oversight bodies.

While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Scope:

• Protocol implementation & coordination
• Data collection, entry, reconciliation
• Patient interaction, procedures, scheduling
• Regulatory compliance & reporting
• Audit preparation
• Process improvement

Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards. Full time presence in the office is required. With department approval 1-2 telecommute days may be permitted.

Qualifications

Education

• Bachelor's degree in Science or Healthcare related field Education Master's degree Science or Healthcare related field

Experience

• Two (2) - Three (3) years of direct clinical research experience
• Two (2) years of oncology clinical research experience
• Two (2) years of patient facing responsibilities
• Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas
• Demonstrated ability to exercise sound judgement
• Intermediate proficiency in Microsoft Office Experience
  
  • Three (3) years of oncology experience
  
  • Three (3) years of patient facing responsibilities

Licensure, Certification, Registration - Required

• Good clinical practice certification or completion within 3 months
• Basic Cardiopulmonary Life Support or completion within 6 months
• Phlebotomy experience or completion of course work within six months of accepting the position
• IATA, dangerous goods, or equivalent training

Preferred

Clinical Research Professional certificate (i.e. ACRP, SOCRA, RAPS)

• ECG certificate or equivalent