Clinical Trials Operations Associate

SHATTUCK LABS, INC.; North Carolina; On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Competitive salary and health benefits

401k benefits

Training and career advancement

Collaborative work environment

Job summary

Shattuck Labs, Durham, NC, is seeking a Clinical Trials Associate to support study teams from start-up through close-out. You will manage study documentation, TMFs, and investigator payments, and assist with CRO/vendor oversight, data review, and biosample reconciliation.

The role requires a science or healthcare degree and at least two years in clinical operations, with familiarity of ICH-GCP and FDA guidelines. Collaboration across functional teams and accurate record-keeping are essential.

Qualifications

• Bachelor’s degree in science or healthcare; minimum 2 years of industry clinical operations/research experience.
• Familiarity with clinical drug development and clinical trial execution.
• Basic understanding of ICH GCP and FDA guidelines.

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

Clinical operations

Clinical trial oversight

Documentation management

Regulatory awareness

Cross-functional collaboration

Communication

Team player

MS Office

Budgeting understanding

Education

Bachelor’s degree in science or healthcare

Tools

MS Office

Job description

Shattuck Labs, Durham, NC, is seeking a Clinical Trials Associate to support study teams from start-up through close-out. You will manage study documentation, TMFs, and investigator payments, and assist with CRO/vendor oversight, data review, and biosample reconciliation.

The role requires a science or healthcare degree and at least two years in clinical operations, with familiarity of ICH-GCP and FDA guidelines. Collaboration across functional teams and accurate record-keeping are essential.