Job Description

About Us

At Rovia Clinical Research, we’re on a mission to bring innovative treatments to patients, improving the health and lives of our local patient communities. We believe in building a workplace where people feel supported, valued, and excited to grow their careers. Whether you’re just starting out or looking for a new path, you’ll be part of a team that truly works together and makes an impact.Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability.

The Source Document Specialist creates, maintains, and executes source documents within the company in accordance with the protocol and contracted scope of work.

Key Responsibilities:

• Creates source documents for all visits related to upcoming research studies.
• Updates source documents for current or upcoming research studies as needed due to protocol amendments, sponsor/CRO requirements, site staff requests, etc.
• Develops and updates company source document templates.
• Maintains organized and up-to-date records of source documents within the appropriate platforms.
• Ensures accuracy, completeness, and compliance of source documents with the associated protocols, regulatory standards, and internal SOPs.
• Provides guidance and support to site staff regarding source documentation, including training on best practices and regulatory standards as needed.
• Reviews source documents created by staff, comparing requirements of the protocol and other resources to the created source.
• May perform other job-related duties as requested or required.

Skills/Abilities:

• Well-versed in the conduct of clinical trials.
• Subject matter expert of ICH/GCP, regulatory requirements, and FDA and HIPAA policies and practices.

Education/Experience:

• Bachelor's degree in a related field or relevant experience required.
• 2+ years in a source documentation role required.