Clinical Research Coordinator II

3 weeks ago


Dallas, Texas, United States Bauer's Intelligent Transportation Full time
Clinical Research Coordinator II Job Description

At Bauer's Intelligent Transportation, we are seeking a highly skilled Clinical Research Coordinator II to join our team. This role is responsible for conducting clinical trials in accordance with federal and hospital regulations.

Key Responsibilities:

  • Facilitate and coordinate daily cancer clinical trial activities
  • Coordinate clinical trials per Good Clinical Practice and CFR guidelines
  • Work directly with on-site research staff, including Investigators, Nurses, and Medical Assistants
  • Accurately and timely collect and report trial data
  • Submit regulatory documents to IRB and Sponsor
  • Attend investigator meetings
  • Obtain physician and staff signatures
  • Recruit subjects/patients
  • Screen, track, and schedule trial patients
  • Coordinate the Informed Consent Process
  • Teach subjects/patients about protocol expectations
  • Perform study/protocol procedures in a detailed and accurate manner
  • Maintain study files completely and accurately
  • Report all adverse events and SAEs within required timelines
  • Collect laboratory specimens, process, and ship lab work
  • Maintain communication and correspondence with subjects, sponsor, monitor, and other site study personnel
  • Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval
  • Respond to all data queries and sponsor requests in a timely manner
  • Coordinate site study monitor and sponsor visits
  • Maintain study-specific supplies
  • Prepare for study closure and archiving
  • Maintain appropriate training required to carry out protocol-driven activities

Qualifications:

  • 3-5 years of equivalent experience in medical clinic or research coordination
  • CCRP, ACRP certification preferred but not required
  • Prior experience with Urology and Oncology clinical trials preferred
  • Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed
  • Some EMR experience required
  • Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience required

Knowledge, Skills & Abilities:

  • Excellent organization and communications skills
  • Strong interpersonal skills to effectively interact with all levels of staff and external contacts
  • Must be detail-oriented and have the ability to follow-through
  • Ability to effectively manage time and prioritize workload
  • Must practice discretion and always adhere to site confidentiality guidelines
  • Knowledge of medical terminology (Oncology and Urology preferred)
  • Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
  • Proficiency with the Microsoft Office Suite, Google Docs, SharePoint


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