Clinical Project Specialist — Mentor & Coordinator

Lexitas Pharma Services, Inc; United States; Remote; USD 60,000 - 85,000; Full time

Job summary

Lexitas Pharma Services, Inc. is seeking a dedicated Project Coordinator to support the Project Management team and study personnel across ophthalmic product development programs.

You will help keep study documentation current and coordinate start-up activities, vendor management, and cross-functional communication. The role emphasizes mentoring junior CRCs, maintaining eTMF and related plans, and ensuring timely progress reports and compliance.

Qualifications

• BA/BS in science/health care or nursing degree preferred
• At least 4 years of clinical research coordinating experience or CRO/pharma/biotech background preferred
• Experience with eTMF and EDC systems preferred
• Capable of mentoring juniorCRC personnel and working with minimal supervision

Responsibilities

• Set up internal and sponsor team meeting invites, agendas and minutes
• CTMS setup and maintenance of project-level information; draft PMP, RMP, eTMF plans
• Draft project status and progress reports for internal and external stakeholders
• Oversee project team training and compliance
• Forecasting and revenue unit tracking including budgets, hours, visits, invoicing
• Coordinate vendor setup and management; ensure approved vendor list compliance
• Maintain project timelines with input from the Project Manager
• Manage DSMB, DMC and other committee logistics

Skills

Customer service

Communication

Attention to detail

Relationship building

Planning and organizing

Problem solving

Education

BA/BS in science/health care

Nursing degree

Equivalent combination of education and experience

Tools

eTMF

EDC systems

Job description

Lexitas Pharma Services, Inc. is seeking a dedicated Project Coordinator to support the Project Management team and study personnel across ophthalmic product development programs.

You will help keep study documentation current and coordinate start-up activities, vendor management, and cross-functional communication. The role emphasizes mentoring junior CRCs, maintaining eTMF and related plans, and ensuring timely progress reports and compliance.