- Company Name
- ARC Regulatory
- Job Title
- Laboratory Placement Student
- Job Description
-
**Job title**
Laboratory Placement Student
**Role summary**
A short‑term, hands‑on laboratory placement for a student working in a regulated research environment. The candidate supports assay development, validation, and routine lab management while adhering to GCP, FDA IDE, EU IVDR, CAP CLIA, and ISO 17025 standards.
**Expectations**
- Gain practical experience with diagnostic assay technologies (IHC, PCR, ELISA).
- Assist in transitioning assays from research use to clinical regulatory compliance.
- Contribute to laboratory maintenance and quality‑assurance processes.
- Collaborate with scientists, regulatory, and clinical teams to meet project milestones.
**Key responsibilities**
1. Aid in development, validation, and re‑validation of diagnostic assays (IHC, PCR, ELISA).
2. Support transfer of pre‑clinical biomarker assays to clinical laboratories, ensuring FDA IDE and EU IVDR compliance.
3. Participate in converting research‑use‑only assays to investigational‑use‑only and IVDR‑compliant formats.
4. Perform routine lab tasks: sample preparation, data recording, equipment maintenance, and inventory management.
5. Follow GCP guidelines and quality standards (CAP CLIA, ISO 17025).
6. Work collaboratively with research scientists, regulatory teams, and clinical trial partners to achieve project objectives.
**Required skills**
- Current enrollment in Biomedical Science, Molecular Biology, Biochemistry, or related field.
- Fundamental laboratory proficiency; familiarity with PCR, ELISA, and IHC preferred.
- Ability to work independently and in a team.
- High attention to detail, strong analytical and organizational skills.
- Effective written and verbal communication.
**Required education & certifications**
- Bachelor’s or graduate‑level coursework in Biomedical Science, Molecular Biology, Biochemistry, or equivalent.
- No specific certifications required, but awareness of GCP, FDA IDE, EU IVDR, CAP CLIA, and ISO 17025 is beneficial.