This applies to routine and non?routine studies in compliance with appropriate company standards, GxP and regulatory guidelines.

Responsibilities:

• Assist and provide guidance to 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
• Works to drive efficiency with external contacts regarding the process for transmitting study sample demographic information
• 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
• Creates and monitor sample logging schedules to ensure samples are logged ready for sample analysis
• Monitors that confirmation of sample receipt communications are confirmed to sponsors and/or study sites in a timely manner
• Reviews QAU report audits. Submits audit responses for approval as appropriate.  Identifies potential process revision as a result of reoccurring inspection items.
• Actively promotes a team environment.
• Provides leadership and training with the Sample Import Coordination team
• Sample reconciliation
• Maintains well documented, organised and up-to-date study files with respect to sample paperwork/inventories
• Participates in and leads the sample accession portion of routine client visits.
• Interacts/communicates with client as necessary.
• Leads the creation and revision of team process in an effort to continually deliver improved service
• Acts as a primary point of contact for process revision and issue resolution between operational groups.
• Maintains involvement with REES monitoring systems and process
• Certified to be an "after hours sample receipt" team member, as appropriate.
• Act as a sample coordinator if needed.
• Performs other related duties as assigned

Requirements:

• Bachelor of Science (BS) degree in science or related field, experience may be substituted for education.
• More than 4 years of Bioanalytical or sample management experience.
• Ability to utilize word processing software, database, spreadsheet, and specialized software.
• Excellent communication, presentation, and interpersonal skills.
• Excellent attention to detail.
• Ability to prioritize and manage time.