Source Document Specialist - Remote

Overview

The Source Document Specialist will be responsible for creating, maintaining, and controlling accurate versions of source documents for clinical trials to substantiate trial activities in a remote work environment.

In Short

• Full-time remote position.
• Create and maintain source documents for clinical trials.
• Ensure compliance with GCP Guidelines and 21 CFR Part 11.
• Coordinate the initial source review and update process.
• Manage version control of all source documents.
• Communicate daily with site staff and internal departments.
• Experience in clinical research preferred.
• Proficient in e-Source build and design.
• Ability to interpret clinical trial protocols.
• Good verbal and written communication skills.

Requirements

• Bachelor's degree in Life Sciences, Healthcare, or related field.
• Experience as a Clinical Research Coordinator preferred.
• Skilled in creating and revising paper source templates.
• Self-motivated and detail-oriented.
• Ability to create source documents in Excel.
• Willing to learn new computerized programs.
• Highly organized with strong IT skills.
• Ability to work well within a team.

Benefits

• PTO/vacation days, sick days, holidays.
• 100% paid medical, dental, and vision insurance.
• 75% coverage for dependents.
• HSA plan.
• Short-term and long-term disability insurance.
• Culture of growth and equality.
• 401k retirement plan.