Source Document Specialist Compliance & Study Workflow Lead

Alliance for Multispecialty Research LLC; United States; On-site; USD 38,000 - 60,000; Full time

Job summary

Alliance for Multispecialty Research LLC is seeking a Source Document Specialist to create and maintain study source documents across assigned studies. The role requires meticulous document control, liaison between study teams, vendors, and sponsors, and ensuring all materials meet GCP and FDA requirements.

You will train team members, review documents for accuracy, support audit readiness, and help streamline workflows. Occasional weekend or overtime may be required; non-exempt status applies.

Qualifications

• Proven ability to manage multiple documents and maintain version control.
• Strong communication with study teams, vendors, and sponsors.
• Experience with source documentation workflows and regulatory expectations.

Responsibilities

• Maintain version control and tracking of all study source documents.
• Serve as 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.
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

Skills

Attention to detail

Verbal and written communication

Team leadership

Organizational skills

Document control

Job description

Alliance for Multispecialty Research LLC is seeking a Source Document Specialist to create and maintain study source documents across assigned studies. The role requires meticulous document control, liaison between study teams, vendors, and sponsors, and ensuring all materials meet GCP and FDA requirements.

You will train team members, review documents for accuracy, support audit readiness, and help streamline workflows. Occasional weekend or overtime may be required; non-exempt status applies.