Biomarker Operations Specialist — Clinical Trials

CRISPR Therapeutics; Boston (MA); Hybrid; USD 85.000 - 100.000; Vollzeit

Benefits dieser Stelle

Bonus

Equity

Benefits

On-site 3 days/wk

Zusammenfassung

CRISPR Therapeutics, based in Boston, MA, is seeking a Clinical Pharmacology Specialist to support PK/PD data flow and biomarker activities in our clinical trials. You will coordinate with Clinical Pharmacology, Data Management, and external labs to ensure timely sample handling and data transfer, while maintaining GCP compliance.

This on-site role offers a hybrid schedule (minimum three days on-site) with opportunities to influence trial execution and drive translational science in a fast-paced

Qualifikationen

• BS in related field with 3-5+ years of experience in clinical trial operations, biospecimen/sample management, or laboratory operations, or advanced degree and 2-4+ years of relevant work experience.
• Strong organizational skills with high attention to detail and accuracy
• Conceptual familiarity with PK, PD, immunogenicity, and biomarker assay types
• Ability to manage multiple concurrent priorities and meet tight timelines across studies
• Working knowledge of GCP and biospecimen handling regulations
• Ability to work independently and collaboratively in a fast-paced, cross-functional, results-oriented team environment
• Experience supporting project budgets and on-time, on-budget delivery

Aufgaben

• Identify vendors to support program-specific biomarker needs.
• Collaborate with Clinical Pharmacology Leads on vendor selection, scope-of-work review, and budget review for selected vendors
• Collaborate with Clinical Pharmacology leads, Finance, and Legal teams to manage contracting and qualification of vendors
• Track biomarker assay timelines and deliverables across multiple concurrent clinical programs
• Liaise with central labs, biorepositories, and CROs to ensure timely sample processing and data transfer
• Coordinate Data Transfer Agreements/Specifications with testing labs and Data Management, and track data transfers against study timelines
• Ensure sample handling adheres to protocol-specific requirements, Good Clinical Practice (GCP), and applicable regulatory guidelines
• File vendor-related documents into the Trial Master File (TMF) to stay inspection-ready (e.g., meeting minutes, sample destruction documents)
• Serve as a key point of contact between Clinical Pharmacology, Clinical Operations, Data Management, Finance, Statistical Programming, and external vendors/labs
• Communicate sample testing status updates, risks, and timeline impacts to study teams
• Contribute to continuous improvement of sample management SOPs and workflows

Kenntnisse

Strong organizational skills

GCP knowledge

Multi-project management

Cross-functional collaboration

Detail-oriented

Ausbildung

Bachelor's degree in related field

Tools

Oracle

Conga

Jobbeschreibung

CRISPR Therapeutics, based in Boston, MA, is seeking a Clinical Pharmacology Specialist to support PK/PD data flow and biomarker activities in our clinical trials. You will coordinate with Clinical Pharmacology, Data Management, and external labs to ensure timely sample handling and data transfer, while maintaining GCP compliance.

This on-site role offers a hybrid schedule (minimum three days on-site) with opportunities to influence trial execution and drive translational science in a fast-paced