Clinical Trials 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

Clinical Trials Associate

Full Time Shattuck Labs, Durham, NC, US

3 days ago Requisition ID: 1083

Salary Range: $75,000.00 To $100,000.00 Annually

About Us

Shattuckians are a diverse group of physicians, scientists, drug developers and protein engineers that are linked through our shared desire to build transformative medicines for patients suffering from life-altering diseases. We are experts in the biology of TNF receptors, including DR3, and have assembled one of the most experienced teams in the industry with regard to understanding the immuno-biology of TNF receptor agonists and antagonists.

Summary

The Clinical Trial Associate will provide support to internal study teams, encompassing a variety of activities from study start-up, through maintenance, to study close-out. The CTA will be responsible for providing trial document and systems management support to Clinical Study Leads throughout trials, including organization of internal filing systems. This role will provide detailed review and oversight of investigator site payments issued by the CRO. This individual may assist study teams with CRO and vendor oversight activities, data review, biosample reconciliation, and clinical supplies.

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.

Qualifications and skills

• Bachelor’s degree in science or healthcare, with a minimum of 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.
• Good organizational skills and operational capabilities.
• Some understanding of clinical trial budgets and accounting.
• Strong interpersonal skills with demonstrated ability to effectively work with internal cross- functional as well as external groups.
• Good communication and interpersonal skills and ability to work with cross-functional teams.
• Self-starter with an entrepreneurial spirit and a good team player.
• Strong computer skills with demonstrated experience in working with the MS Office platform.

Employee Benefits

• Competitive salary and health benefits, 401k.
• Opportunities for training and career advancement.
• Collaborative and inclusive work environment.
• Access to cutting-edge research and technology.