Responsible for coordinating the accuracy of all sample related information which are entered into the LIMS system. Monitoring the sample logging process to ensure that the required timelines for analysis are met. Responding to and resolving sample management questions with respect to shipments and samples. Reconciling samples in LIMS.
This applies to routine and non-routine studies in compliance with appropriate company standards, GxP and regulatory guidelines.
Duties and Responsibilities:
- Assist Study Director (SD)/Principal Investigator (PI)/Study Coordinator (SC) in study set-up regarding study samples.
- Prepares or checks demographic import files and coordinates the preparation of tube labels
- Assurance of accurate protocol interpretation
- Ensuring the LIMS system is up to date with expected samples.
- Performs checks on demographic data for study samples to confirm consistency between the tube labels, LIMS system and the supplied paperwork when requested by sample management to resolve issues.
- Resolve discrepancies, with responsibility for confirming and correcting any anomalies in the LIMS system.
- Responsible to ensure any discrepancies which are highlighted by the sample receipt technicians are resolved
- Monitors sample logging schedules to ensure samples are logged ready for sample analysis
- Reviews QAU report audits. Submits audit responses for approval as appropriate.
- Monitors that confirmation of sample receipt communications are confirmed to sponsors and/or study sites in a timely manner
- Sample reconciliation
- Maintains well documented, organized and up-to-date study files with respect to sample paperwork/inventories
- Participates in routine client visits.
- Interacts/communicates with client as necessary.
- Performs other related duties as assigned
• Bachelor of Science (BS) degree in science or related field. • Experience may be substituted for education.• Ability to utilize word processing software, database, spreadsheet, and specialized software.
• 2 years of Bioanalytical or sample management experience required. • Excellent communication, presentation, and interpersonal skills.• Excellent attention to detail.• Ability to prioritize and manage time.