Senior Clinical Trial Associate

Scorpion Therapeutics; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced Senior Clinical Trial Associate to join the Clinical Operations team, supporting early-stage CAR-T oncology trials. You will coordinate regulatory documentation, TMF/eTMF maintenance, and cross-functional study activities to ensure compliance with ICH-GCP and SOPs.

The role involves trial planning, site coordination, and collaboration with vendors and CROs, with a focus on maintaining study timelines and quality across Phase I/II programs.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 3–5 years as a Clinical Trial Associate (or similar role).
• Experience with trial coordination, regulatory documentation, and site management.
• Oncology trial experience required; cell therapy and/or CAR-T strongly preferred.
• Strong ICH-GCP/regulatory understanding; proficiency with CTMS, eTMF, and EDC.
• Excellent organization, communication, problem-solving; ability to work cross-functionally.
• Proficiency in Microsoft Office; familiarity with eTMF/EDC platforms.

Responsibilities

• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study forums.
• Support Senior Clinical Trial Managers with day-to-day execution of Phase I/II CAR-T oncology trials in compliance with ICH-GCP and applicable regulations.
• Oversee preparation, organization, and maintenance of trial documentation (regulatory files, TMFs/eTMFs, correspondence); ensure documents are current, complete, and compliant with ICH-GCP and company SOPs.
• Assist with trial planning, start-up, execution, and close-out; coordinate with sites and support protocol/regulatory compliance.
• Prepare, submit, and track regulatory and IRB/IEC documents; maintain knowledge of applicable regulations and standards.
• Schedule/coordinate meetings (investigator meetings, site visits, internal meetings); prepare agendas, minutes, track action items.
• Track trial progress (site activation, enrollment, monitoring, milestones) and maintain status reports/trackers.
• Support data management (query tracking and data reconciliation) with Data Management.
• Liaison among clinical team, vendors, CROs, and investigational sites; support vendor oversight.
• Identify operational issues/risks, propose solutions, and elevate as appropriate; improve processes; mentor junior CTAs.

Skills

Cross-functional collaboration

Regulatory understanding

Attention to detail

Communication

Problem solving

Education

Bachelor’s degree in life sciences

Tools

CTMS

eTMF

EDC

Microsoft Office

Job description

Role Overview

Senior Clinical Trial Associate (Sr. CTA) on the Clinical Operations team to support early-stage clinical development, executing complex Phase I/II CAR-T oncology trials with operational, administrative, and coordination support.

Key Responsibilities

• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study forums.
• Support Senior Clinical Trial Managers with day-to-day execution of Phase I/II CAR-T oncology trials in compliance with ICH-GCP and applicable regulations.
• Oversee preparation, organization, and maintenance of trial documentation (regulatory files, TMFs/eTMFs, correspondence); ensure documents are current, complete, and compliant with ICH-GCP and company SOPs.
• Assist with trial planning, start-up, execution, and close-out; coordinate with sites and support protocol/regulatory compliance.
• Prepare, submit, and track regulatory and IRB/IEC documents; maintain knowledge of applicable regulations and standards.
• Schedule/coordinate meetings (investigator meetings, site visits, internal meetings); prepare agendas, minutes, track action items.
• Track trial progress (site activation, enrollment, monitoring, milestones) and maintain status reports/trackers.
• Support data management (query tracking and data reconciliation) with Data Management.
• Liaison among clinical team, vendors, CROs, and investigational sites; support vendor oversight.
• Identify operational issues/risks, propose solutions, and elevate as appropriate; improve processes; mentor junior CTAs.

Requirements

• Bachelor’s degree in life sciences/clinical research or related field.
• 3–5 years as a Clinical Trial Associate (or similar role).
• Experience with trial coordination, regulatory documentation, and site management.
• Oncology trial experience required; cell therapy and/or CAR-T strongly preferred.
• Strong ICH-GCP/regulatory understanding; proficiency with CTMS, eTMF, and EDC.
• Excellent organization, communication, problem-solving; ability to work cross-functionally.
• Proficiency in Microsoft Office; familiarity with eTMF/EDC platforms.

Benefits

• Benefits are offered exclusively to permanent full-time employees (contractors not eligible).

Work Authorization

Applicants must be authorized to work in the United States; E-Verify and Form I-9 required if hired.