Research Scientist PI – Bioanalytical
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Virginia • United States
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Tech Stack
About the role
- Acts as sponsor representative/study monitor for several studies
- Supports bioanalytical phases of clinical trials
- Reviews trial documentation and ensures the bioanalytical vendor receives required documents
- Reviews and approves study plans and reports
- Manages changes to study plans and vendor procedures, documenting them per requirements
- Ensures clinical trial team is informed about project status
- Escalates issues related to timelines, budget or communication
- Manages oversight documentation in eTMF
- Contributes to interactions with regulatory agencies
Requirements
- PhD in Immunology or Molecular Biology (3+ years experience) or Master's Degree in life sciences (6+ years experience)
- Experience in managing outsourced activities at external vendors
- Strong knowledge of bioanalytical techniques in biologics and antibodies assays
- Experience performing PK and ADA assays
- Experience analyzing human samples in support of clinical trials
- Strong understanding of GCP/GCLP guidelines and other global regulations
- Experience with submission documentation and regulatory interactions
- Experience with clinical immunogenicity data interpretation and writing clinical study reports
- Ability to draft and review bioanalytical modules and regulatory documents independently or with a medical writer
Benefits
- Standard work schedule (Mon-Fri)
- Comprehensive background check including drug screening
- Full-time benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
bioanalytical techniquesPK assaysADA assaysclinical trial documentationregulatory document writingclinical immunogenicity data interpretationstudy plan managementvendor managementeTMF managementbioanalytical module drafting
Soft Skills
communicationproblem-solvingproject managementteam collaborationissue escalationorganizational skillsindependent workattention to detailinterpersonal skillsleadership
Certifications
PhD in ImmunologyPhD in Molecular BiologyMaster's Degree in life sciences