Clinical Trial Associate

Scorpion Therapeutics; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced clinical operations support professional to assist the project team with trial execution in accordance with ICH/GCP guidelines. You will manage TMF documents, coordinate meetings, and support audit preparations.

The role requires strong document control, attention to detail, and proficiency with Veeva TMF and standard office tools. Collaboration across departments and vendors is essential.

Qualifications

• Bachelor’s degree or nursing degree required; healthcare field preferred.
• Minimum 4 years’ experience in clinical trial settings.
• Good Clinical Practice training and knowledge of clinical guidelines.
• Proficient with Veeva TMF and standard office software.
• Strong attention to detail and deadline management.
• Professional communication across vendors and teams.

Responsibilities

• Manage trial documents in Veeva Vault TMF and train new users.
• Upload and review TMF documents for completeness and compliance.
• Perform quality checks and follow up on open issues.
• Audit TMFs and resolve discrepancies.
• Create and maintain internal folders on company drives.
• Coordinate cross-functional project team meetings and track actions.
• Assist in study materials creation and reporting.
• Support CPM with tracking tools for site activation and enrollment.
• Assist with audits/inspections preparation.
• Participate in inter-departmental process improvement workgroups.

Skills

MS Word

MS Excel

MS PowerPoint

MS Outlook

Attention to detail

Communication

Cross-functional collaboration

Time management

Education

Bachelor's degree

Nursing degree

Tools

Veeva TMF

Job description

Summary:

Responsible for assisting and providing support to the clinical operations project team to facilitate operational execution of clinical trial processes in accordance with regulatory guidelines and ICH/GCP standards.

Responsibilities:

• Manages trial-related documents in Veeva Vault TMF; manages user access and facilitates training; trains new users.
• Uploads and reviews TMF documents for completeness, accuracy, and compliance with protocol, regulations, SOPs, and best practices.
• Performs quality checks and follows up on resolution of open issues to ensure cross-functional compliance with TMF required documents.
• Audits TMFs and resolves discrepancies with minimal supervision.
• Creates and maintains internal folders on company share drive(s).
• Manages study investigator CDAs, contract approval, and purchase order creation.
• Coordinates cross-functional project team meetings; assists with agendas, minutes, and tracking action items.
• Assists in creation of study materials (documents, presentations, reports).
• Supports CPM to establish and maintain tracking tools for project metrics (site activation, patient enrollment, site contacts).
• Reviews and assists in collection of essential documents for completeness and compliance.
• Creates and reviews IMP release packet prior to initiation; reviews potential new site background (e.g., debarment check, inspection history).
• Assists study teams and sites with preparation for audits/inspections.
• Participates in inter-departmental workgroups to create/enhance processes.
• May train CRO teams/investigators/study team; may serve as vendor point of contact.
• May update Clintrials.gov; performs administrative tasks to support clinical trial execution.

Qualifications:

• Bachelor’s degree or nursing degree required; scientific/healthcare field preferred (not required).
• Minimum 4 years’ experience in relevant field (clinical site, CRO, Sponsor, or clinical trial vendor).
• Relevant experience in clinical research or related field.
• Adequate Good Clinical Practice training; general knowledge of clinical research guidelines.
• Comfortable with technology; ability to learn new systems quickly.
• Experienced with Veeva TMF.
• Strong MS Word, Excel, PowerPoint, and Outlook.
• Strong attention to detail; ability to prioritize, schedule, and meet deadlines.
• Professional communication with visitors, vendors, and all organizational levels.
• Ability to work in fast-paced environment and on multiple competing tasks.
• Ability to work successfully within a cross-functional team.