Clinical

Job Description:
• Ensuring that samples acquired during the conduct of a drug trial are processed, stored, shipped in a manner that maintains specimen integrity. Review of queried reports to QC sample processing and bring to the attention of Operations Director any major protocol deviations and or discrepancies.

• Support sample processing and verification of specimen compliance

• Identify day to day requirements for study sample processing and ensure that Laboratory is prepared to support these tasks.

• Maintain proper inventory of items necessary to support the processing and storage of clinical trial samples

• Oversee the requisitioning and transport of safety samples that are outsourced. Own it.

• Perform the duties and requirements of Laboratory Study Co-lead.

• Record daily schedule for the following day by printing Dashboard schedule, 2 copies, deliver to SPL and Safety Lab. Display brief summary of next day's activities (including date) on the white board by the dumbwaiter.

• Ensuring that samples acquired during the conduct of a drug trial are processed, stored, shipped in a manner that maintains specimen integrity. Once or twice a day, review of queried reports (Toad) to QC sample processing and bring to the attention of the Laboratory Manager or Specimen Processing Lead any major protocol deviations and or discrepancies who will then review issues with the lab.

• Document discrepancies on the electronic copy and save to the TAT folder.

• Also include investigation comments in an additional column

• Review daily Specimen Processing bench logs for compliance

• Identify day to day requirements for study sample processing and ensure that Laboratory is prepared to support these tasks with trained personnel

• Maintain inventory of items necessary to support the processing and storage of clinical trial samples

• Enter send out results as performed.

• Exhibit behavior by example, staying busy, ensuring the lab is covered at all times and new staff is not left alone

Hard Skills:

1. Strong background Sample and Specimen Processing (logging and reviewing for accuracy)

2. QC Exp./Compliance Exp.

3. Inventory Maintenance