Source Document Specialist

Alliance For MultiSpecialty Research LLC • US,

10d

About The Position

The role of the Source Document Specialist is responsible for creating and maintaining study source documents throughout assigned studies. The Source Document Specialist reports to the Source Document Team Lead. This is a Non-Exempt position.

Requirements

• At least 6 months of medical experience.
• Ability to operate basic office equipment including but not limited to copy machines, facsimile machines and computers.
• Strong verbal and written communication skills
• Strong interpersonal skills
• Positive, collaborative, team mentality
• Excellent task management and prioritization skills
• Build and cultivate long term relationships
• Excellent follow up
• Drive and initiative
• Fluent in English.

Nice To Haves

• Ability to effectively lead a high-performance team
• Devote keen and acute attention to detail

Responsibilities

• Maintain version control and tracking of all study source documents.
• Serve as a liaison between study teams, vendors, and sponsors to ensure document accuracy and completeness.
• Communicate with study coordinators and investigators to clarify documentation requirements.
• Provide training and guidance to team members on best practices for source documentation.
• Identify opportunities to streamline source document workflows for improved efficiency.
• Ensure source documents comply with Good Clinical Practice (GCP), FDA, and sponsor requirements.
• Assist with audit preparation by ensuring all source documents are complete and readily accessible.
• Maintain confidentiality and data security in handling sensitive study-related information.
• Create study source documents, utilizing the study protocol, lab manual, pharmacy manual and EDC guidelines for each study.
• Review and approve created study documents for each study. Ensuring accuracy and all components of the study are captured.
• Maintain and evolve efficiencies within the department
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed