Clinical Trials Operations Specialist

Shattuck Labs, Inc.; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Shattuck Labs, Inc. is seeking a Clinical Trial Associate to support internal study teams through start-up to close-out, ensuring robust trial documentation and TMF maintenance.

You will oversee investigator payments and assist with CRO/vendor oversight, data review, biosample reconciliation, and clinical supplies management. The role requires a science/healthcare background with 2+ years in clinical operations, familiarity with trial execution, and strong organizational and cross-functional

Qualifications

• Bachelor’s degree in science or healthcare; 2+ years clinical ops/research experience.
• Familiarity with clinical drug development and trial execution.
• Basic understanding of ICH GCP and FDA guidelines.
• Strong organizational and operational capabilities.
• Some understanding of trial budgets and accounting.
• Strong communication and cross-functional collaboration.

Responsibilities

• Assist internal study teams in study operations, CRO/vendor oversight activities, and study tracking.
• Support clinical study documentation preparation, tracking and maintenance.
• Maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs.
• Support financial tasks for the study (e.g. investigator grant payments), coordinating tracking and validating CRO payments.
• Develop Clinical Study Report appendices, with oversight from the Clinical Study Lead.
• Assist with regular data review and data cleaning.
• Coordinate trial logistics in collaboration with the CRO(s), including tracking of trial supplies, biological samples, and drug, as needed.
• Maintain and update the study team list, including vendor contact information.
• Ensure internal team training tracking and completion as appropriate.
• Maintain and manage requests for access to and deactivation of study systems users.
• Work with functional teams to identify potential risks and develop contingency plans.
• Attend relevant operational meetings for assigned clinical trials, taking meeting minutes as needed.
• Ensure adherence to all regulatory requirements, company policies, and industry standards including FDA regulations and ICH-GCP guidelines.

Skills

Organizational skills

Interpersonal skills

Communication

Cross-functional collaboration

Self-starter

Education

Bachelor’s degree in science or healthcare

Tools

MS Office

Job description

Shattuck Labs, Inc. is seeking a Clinical Trial Associate to support internal study teams through start-up to close-out, ensuring robust trial documentation and TMF maintenance.

You will oversee investigator payments and assist with CRO/vendor oversight, data review, biosample reconciliation, and clinical supplies management. The role requires a science/healthcare background with 2+ years in clinical operations, familiarity with trial execution, and strong organizational and cross-functional