Senior Research Assistant, Lab Sciences - United States
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- Serve as lead/primary technician for both complex and highly complex studies in Laboratory Sciences disciplines.
- Perform special, non-routine projects in the laboratory, as assigned.
- Responsible for developing and performing laboratory procedures.
- Develop new techniques, procedures, or scientific innovations that expand the capabilities of the department.
- Provide leadership and technical guidance in the laboratory and assist in the coordination of resource planning.
- Perform analysis of complex and highly complex laboratory assays based on protocols and in compliance with Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs) regulations.
- Perform laboratory procedures and collect and record/document research data in compliance with GLPs, SOPs, study protocols, study- and laboratory-specific methods or procedures, and company policies/practices. Review the activities and documentation contributing to the study, and assure full adherence to the study requirements.
- Perform study preparation activities including but not limited to the preparation and maintenance of study notebooks, generating data collection documentation, identifying supply needs, performing laboratory setup, and developing and implementing Study Specific Procedures (as appropriate). Generate simple to highly complex tables for data input and report generation. Print and edit computer entries (e.g., laboratory data) as needed.
- With guidance from scientific staff: review, interpret and integrate data on assigned studies; assist in generating study protocols and assist in sponsor correspondence and interactions; participates in method development, refinement, and validation.
- Record project data in accordance with GLP regulations to include creation of Laboratory Methods, data package assembly and assisting in the quality control of project work.
- Assist in the execution of all study related activities required across all studies including the scheduling of daily work and technical staff.
- Review study protocols and provide recommendations on technical and logistical aspects of protocol design.
- Participate in preparing responses to both internal and external quality assurance audits.
- Set up laboratory instrumentation utilizing departmental and instrumental software with minimal supervision.
- Troubleshoot laboratory instrumentation and perform basic maintenance.
- Manage and coordinate project timelines, resource coordination, and prioritization of assigned studies in conjunction with laboratory management.
- May provide technical direction and mentoring to less experienced staff in specific study-related laboratory processes and procedures.
- Adhere to current health and safety regulations.
- Perform all other related duties as assigned.
- Education: Bachelor’s Degree (B.S./B.A) or equivalent in biology, chemistry/pharmacy, or similar lab environment or must have demonstrated full knowledge of competencies and positive performance at the previous level.
- Experience: Five to eight years previous directly related GLP laboratory experience in a pharmaceutical or contract laboratory environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Exceptional analytical and problem solving capabilities.
- Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and GLPs, as appropriate.
- Fully proficient in technical skills and the operation of data collection equipment.
- Must be able to perform effectively as a team member, accurately record data, follow verbal and written instructions, communicate effectively and interact in a professional manner with management, coworkers and sponsors.
- Excellent written and verbal communication skills.
- Able to prioritize work and meet deadlines.
- High level of proficiency in the use of standard software and be able to quickly learn and utilize computer programs as needed.