LIMS Clinical Studies Specialist - (Full-time) - Onsite - Quebec Canada

Contract Research Organization seeks a full-time onsite LIMS Clinical Studies Specialist with 2+ years' experience working within Clinical Research within a CRO. This person should have expertise in LIMS, and SampleManagement, Ligand Binding Assays, and/or Mass Spectrometry. Additionally, this individual should have a thorough understanding of Study Protocols and Plans from various phases of Clinical Trials (Phases I-IV) and Safety Assessment (ideally Preclinical Toxicology Studies). Lastly, experience and knowledge having worked within a GLP and GCP environment and writing SOPs are also required. Opportunity offers competitive base compensation based on individual expertise and seniority. Also offered are benefits, competitive PTO, and a Group RRSP with an employer match of 100% of individual contribution each pay period, up to 3% of annual salary.

REQUIREMENTS

• Canadian Citizenship or Work Permit.
• Location within Canada, ideally already local to Quebec.
• Ability to work full-time from organizational onsite location.
• Valid passport for US travel, as necessary.
• BSc. Or higher degree in Life Sciences or related area.
• Experience working for a CRO and within regulated environments to include FDA, GLP, GCP and TPD.
• 2+ years in Clinical Research with 1+ years exposure to LIMS.
• A history of working within Clinical studies coordination to include dealing with Study Protocols and Plans from various clinical trials (phases I-IV), and Safety Assessments (Pre-Clinical Toxicology Studies).
• Experience with SampleManagement, Ligand Binding Assays and/or Mass Spectrometry.
• Knowledge of concentrations storage and reporting.

RESPONSIBILITIES

• Primarily responsible for the coordination of study designs in support of internal/external activities within the organization.
• Supporting all users of Watson LIMS and study design related issues/questions; users include Watson Designers, Study Director/BPI, Sample Manager Teams, and Clinical/Pre-Clinical Sites.
• Performing sample reconciliation as needed.
• Providing colleague training on study designs cross departmentally to include training documentation creation and updates, new employees on LIMS/study designs, and more.
• Supporting study design creation and employee training for other sites.
• Creating and verifying Watson LIMS study designs based upon study protocols, while coordinating design requests and assigning these to appropriate members.
• Investigating and resolving issues related to study designs.
• Performing sample associations based upon sponsor manifests.
• Facilitating study designs for data reporting.
• Contributing to study design assessment meetings to determine best approach in the creation of study protocols.
• Managing discrepancies related to sample reception.
• Authoring file memos, while ensuring proper execution.
• Generating reports as required for various uses.
• Working with IT department to solve problems as well as with IT validation teams to perform UAT and test Cases.
• Participating regularly within process improvement initiatives.
• Working closely with QC reviews and Sample Management teams, while also participating in SOP reviews and updates.
• Writing and editing SOPs as needed and conducting all work in compliance with SOPs as well as GLPs and GCPs, while observing all organizational guidelines and policies.
• Ability to troubleshoot LIMS sample processing through the understanding of how samples are logged into, tracked and then maintained within the system.