Clinical Research Coordinator II

4 weeks ago

Orlando, United States DLCFL Full time
Job DescriptionJob Description

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

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