Clinical Research Coordinator II (CRC)

This position is responsible for performing highly diverse clinical and administrative responsibilities requiring a high level of knowledge and attention to detail. This position requires assimilating vast amounts of information and processing information promptly and orderly. Personnel who fill this role must have a working knowledge of ICH/GCP guidelines. Specific studies are assigned as appropriate, and the coordinator is accountable to the Principal Investigator, Medical Director, and Clinical Research Manager.

Qualifications

• 1+ years of previous experience required as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials
• Computer skills - Microsoft Word, Excel, PowerPoint, CTMS, EMR
• Previous experience in a role of complex administration or project coordination
• Effective communication skills, including written, verbal, and presentation skills
• Strong attention to detail and organizational, analytical, and problem-solving skills
• Periodic local travel to other practice locations on an as-needed basis

Supervisory Responsibilities

This position may serve a role in supporting/ mentoring junior coordinators and research assistants

Job Duties/Responsibilities

• Ensure the rights, safety and welfare of all subjects at all times
• Ensure that each subject goes through the informed consent process following GCP guidelines, and consents to participate, before any study-related procedures are performed
• Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately
• Work in a collaborative, effective manner with Site personnel to meet research objectives completely and accurately
• Responsible for understanding all internal policies and procedures approved by the Principal Investigator/Medical Director
• Discuss study protocols with patients and verify informed consent documentation
• Review patient medical history against Inclusion/Exclusion Criteria of studies
• Perform blood draws, process and shipping of blood/urine specimens per study protocol and IATA regulations
• Schedule all patient research visits and procedures consistent with protocol requirements
• Dispense study medication, collect vital signs, and perform ECGs
• Assist with routine data verification and quality control, ensuring data integrity and consistency with the prescribed study protocol
• Provide the Sponsor with accurate and complete documentation and information
• Provide accurate and complete documents for IRB submission on a timely basis
• Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements
• Retain and/or forward copies of forms as required by the Sponsor
• Inform Sponsor of prospective FDA audits immediately
• Prepare for FDA or Sponsor audit by ensuring all documentation and case report forms are available and complete
• Provide subject education on an ongoing basis throughout their participation in the study
• Report all adverse events to the Investigator, Sponsor and IRB.
• Complete Study Logs in an accurate and timely manner in the appropriate electronic data system
• Utilize a team approach including the PI, Sub-Investigators, other Coordinators and Research Assistant
• Assist in the training of new staff members
• Other duties as assigned