Cancer Clinical Research Coordinator Associate – Hematology (Hybrid)

Core Duties

• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Cook up studies from start-up through closeout.
• Determine eligibility of and gather consent from study participants according to protocol.
• Aid in developing recruitment strategies.
• Cook up study specimens and process them.
• Collect and manage patient and laboratory data for clinical research projects.
• Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
• Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

  Desired Qualifications

  • Knowledge of the principles of clinical research and federal regulations.
  • Familiarity with IRB guidelines and regulations.
  • Previous experience with clinical research.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
  • Strong oral and written communication skills.
  • Excellent attention to detail.
  • Proficiency in using computers, software, and web-based applications in a previous administrative setting.