Clinical Research Coordinator

3 days ago

Saint Peters, Missouri, United States ELIXIA LLC Full time
About the Job

We are seeking a highly skilled and motivated Clinical Research Coordinator to join our team at ELIXIA LLC. As a Clinical Research Coordinator, you will play a critical role in ensuring the success of our research studies.

Key Responsibilities:

  1. Coordinate project planning and execution with Study Coordinators.
  2. Maintain accurate records and documentation of study activities.
  3. Ensure compliance with regulatory requirements and company policies.
  4. Recruit and coordinate research subjects as needed.
  5. Perform patient care duties as directed by the Principal Investigator and study protocol.
  6. Develop and maintain source documentation for capturing data on study protocols.
  7. Inventory management of research and laboratory supplies.
  8. Maintain lab logs, Investigational Product (IP) logs, and Transportation logs as needed.
  9. Order lab kits and supplies.
  10. Answer incoming calls and contact study subjects when necessary.
  11. Recruit study subjects appropriate for screening as per protocols inclusion/exclusion criteria.
  12. Ensure study enrollment goals are met as per sponsor requirements.
  13. Maintain a clean and organized office and lab environment.
  14. Manage and organize study files.
  15. Request medical records when needed.
  16. Collect necessary laboratory specimens, EKG, and subject questionnaires.
  17. Complete informed consent procedures in accordance with site SOPs and FDA/GCP guidelines.
  18. Facilitate the smooth and efficient operation of research and data collection activities.
  19. Inventories protocol shipments, such as drugs, labs, and café report forms (CRFs).
  20. Maintain cleanliness and supplies in exam rooms and laboratories.
  21. Assist and/or work in lab as needed.
  22. Complete all study-specific trainings as assigned by sponsors, ensuring timely completion in accordance with sponsor requirements for study initiation.
  23. Attend Site Initiation Visits (SIV) to prepare for study initiation.
  24. Maintain phone logs of communications with patients and trial sponsors.
  25. Update study logs, including screening, subject identification, and enrollment logs.
  26. Prepare research binders.
  27. Obtain signatures from Principal Investigator(s) and Sub-Investigator(s).
  28. Update the research Clinical Trial Management System (CTMS).
  29. Prepare source documents, records, and algorithms.
  30. Assist in the preparation of documents for submission to the sponsor and Institutional Review Board (IRB).
  31. Obtain blood and other specimens as required.
  32. Pick up lab samples and transport them back to the laboratory.
  33. Process lab specimens and prepare lab shipments.
  34. Transport lab tubes and medications from the office to other site units.
  35. Perform vital assessments of patients and document on designated logs.
  36. Ensure confidentiality of subjects' health information and all study-related information.
  37. Notify manager of abnormal laboratory values or clinical observations.
  38. Communicate with central lab regarding abnormal lab values.
  39. Perform research study visits as assigned.
  40. Schedule patient visits for studies and prepare source documents for follow-up visits.
  41. Maintain adequate documentation on patient source documents, the Company's CTMS system, and via e-mail.
  42. Provide assistance and training to new and current staff members.
  43. Occasional travel to Company sites, Investigator meetings, and/or Company meetings.
  44. Perform other miscellaneous job-related duties as assigned by your manager, Clinical Research Coordinators, or other management members.

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