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.
