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Clinical Research Associate

2 months ago

Waltham, United States BostonGene Full time

Job Summary:

The Research Associate at BostonGene is responsible for supporting the clinical laboratory's daily operations, ensuring quality control, and contributing to various research projects. This role involves performing clinical immunohistochemistry (IHC), optimizing IHC and immunofluorescence (IF) methods, maintaining laboratory equipment, and conducting experiments. The position requires onsite presence during regular business hours, with some weekend support for technical assistance. The Research Associate will work collaboratively with scientific teams, adhere to regulatory standards (GCLP, GCP, CLIA, and CAP), and support the preparation of essential documentation to ensure compliance.


Responsibilities:

  • Perform clinical immunohistochemistry (IHC) using Dako Omnis and Leica Bond systems, following established Standard Operating Procedures (SOPs). This includes microtome work, preparing H&E stains, and scanning slides with Huron and Perkin Elmer scanners.
  • Optimize IHC and immunofluorescence (IF) methods, including both multiplex and low-plex studies, and demonstrate a willingness to learn new techniques.
  • Execute biopharma and clinical trial projects under the supervision of a designated mentor, adhering to Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP) standards.
  • Compile comprehensive research reports and present findings to internal teams.
  • Understand and troubleshoot assay procedures and instrumentation as required.
  • Work flexible hours to support low-plex, clinical IHC and histology tasks, and manage multiple responsibilities efficiently.
  • Conduct routine maintenance checks on laboratory equipment daily, weekly, monthly, or as needed.
  • Assist with various research and clinical tasks, such as reagent preparation, material ordering, and lab organization.
  • Use the Laboratory Information Management System (LIMS) and Benchling to monitor, record, and process samples accurately.
  • Collaborate on updating and creating SOPs to improve processes and comply with new regulations.
  • Support the preparation and maintenance of CLIA/CAP and GCLP documentation to ensure regulatory compliance.


Minimum Qualifications:

  • Bachelor’s or Master’s degree in Biology or a related discipline, with a minimum of one year of relevant experience.
  • Prior experience in IHC, microtome sectioning, and histology.
  • Excellent oral and written communication skills.
  • Willingness to learn new methods and adapt to evolving laboratory practices.
  • Ability to thrive in a dynamic work environment and manage changing priorities effectively.


Skills:

  • Technical Proficiency: Understanding of immunohistochemistry (IHC) and immunofluorescence (IF) techniques, including multiplex and low-plex methods.
  • Laboratory Skills: Proficiency in using Dako Omnis, Leica Bond, Huron, and Perkin Elmer scanners, along with experience in microtome sectioning and H&E staining.
  • Analytical Abilities: Skilled in compiling comprehensive research reports and presenting data clearly.
  • Problem-Solving: Effective troubleshooting of assays and instrumentation issues.
  • Collaboration: Excellent interpersonal skills for fostering relationships with technical and scientific colleagues across departments.
  • Time Management: Ability to handle multiple tasks efficiently, including time-sensitive experiments and flexible working hours.
  • Regulatory Compliance: Knowledge of GCLP, GCP, CLIA, and CAP standards, with experience in supporting regulatory documentation.
  • Technical Software: Proficient in using Laboratory Information Management System (LIMS)s such as Benchling for sample monitoring and processing.


About BOSTONGENE:

BostonGene Corporation pioneers biomedical software for advanced patient analysis and personalized therapy decision-making in cancer treatment. Our solution integrates cutting-edge cancer research and clinical data to empower clinicians in tailoring optimal treatment strategies for individual patients.