Source Document Specialist

Role Responsibilities:

• Create, maintain, and control accurate versions of source documents for each clinical trial to substantiate trial activities.
• Design e-Source and paper source templates based on thorough protocol reviews and ensure compliance with GCP Guidelines and 21 CFR Part 11.
• Coordinate initial review, update processes, and maintain version control for all source documents.
• Manage daily communication with site staff and internal departments to support trial operations.

Qualifications:

• Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.
• Skilled in e-Source build and design using tools like CRIO or Clinical Conductor.
• Ability to interpret clinical trial protocols and design accurate, complete source documents.
• Proficiency in Excel and willingness to learn computerized programs for eSource creation.

Work Environment:

• Remote position with 100% work performed from a home office within the United States.
• Less than 10% travel required for occasional planned trips.
• Physical demands include ability to use keyboards and other computer equipment.

Benefits:

• Paid Time Off and Company Paid Holidays.
• 100% employer paid medical, dental, and vision insurance options.
• Health Savings Account and Flexible Spending Accounts with bi-weekly HSA employer contribution.
• Company paid Short-Term and Long-Term Disability, and 401(k) Retirement Plan with Company Match.