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Job Overview
Support the day to day operations to laboratories to deliver on sponsor requests and studies, including oversight of technical processes and procedures insofar as they impact pathology interpretations. Perform microscopic analyses of laboratory assays and monitor digitization of slides. Correlate clinical information with pathology findings. Release timely reports into LIMS for sponsor and/or clinical site action. Participate in or initiate internal and client-facing communications. Interact collegially with other pathologists, customers, vendors and employees in order to achieve shared goals. Act as Principal Investigator on clinical trials and communicate with clients and colleagues on study progress..; Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
- Review and score Immunohistochemistry and FISH slides.
- As part of a team, establish new histopathology assays in the laboratory.
- Provide pathologist input to discussions with clinical trial sponsors to ensure delivery of the goals of the clinical trial in an efficient and cost-effective manner, ensuring that the highest standards of quality and customer service are maintained.
- Maintain professional qualifications and accreditations in line with relevant authorizing bodies and continuing professional development.
- Review routine histopathology slides on daily basis to enable the lab to meet turnaround times for enrollment of patients into clinical trials.
- Establish and provide morphological diagnosis on H & E stained slides on both oncological and general surgical pathology samples as per clinical trial requirements.
- Evaluate laboratory information.
- Report results in accordance to protocols mandated by the regulatory requirements.
- Maintains medical laboratory equipment performance by establishing quality standards
- developing operations, quality, and troubleshooting procedures.
- Develop and implement diagnostic and analytical procedures.
- Other duties as assigned.
- Other Medical degree or foreign equivalent at the Licensed Physician level and certification in anatomic pathology Req
- Typically requires 5 - 7 years of prior relevant experience or equivalent combination of education, training and experience.
- Preferred experience working in a reference lab, clinical research organization, and/or clinical trials.
- Excellent written and oral communication skills.
- Excellent client management and problem resolution skills.
- Knowledge of PC applications.
- High ethical standards.
- Ability to meet average industry performance metrics, as well as metrics outlined by the company.
- Proficient in routine histopathology testing, immunohistochemistry (IHC), cytogenetics (In-situ hybridization) testing procedures and applicable laboratory testing regulations.
- Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
- Remain aware of scientific and other advances, as the subject matter expert for department. Develop and maintain skills and knowledge appropriate to the post by undertaking training and attending meetings and conferences.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to bring projects and deliverables to completion under timeline expectations.
- Knowledge of occupational safety and health rules and regulations.
- Other Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://q2labsolutions.com/careers
