Source Document Specialist

AMR Clinical; Northern (KY); Hybrid; USD 40,000 - 55,000; Full time

Job summary

AMR Clinical is seeking a Source Document Specialist for a full-time role in the United States. You will create and maintain source documents across studies, serve as a liaison with study teams, sponsors, and vendors, and ensure accuracy and regulatory compliance.

You will train team members, streamline workflows, and protect confidentiality of sensitive information. Weekend or overtime may be required on occasion.

Qualifications

• At least 6 months of medical experience.
• Ability to effectively lead a high-performance team.
• Strong verbal and written communication skills.
• Strong interpersonal skills and collaboration.
• Detail-oriented with keen organizational abilities.
• Experience with study documents and regulatory standards is a plus.

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
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

Skills

Attention to detail

Verbal and written communication

Team leadership

Task management

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Source Document Specialist

Full Time US

2 days ago Requisition ID: 1323

The role of the Source Document Specialist is responsible for creating and maintaining study source documents throughout assigned studies.

To consistently embody AMR Clinical’s Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

The Source Document Specialist reports to the Source Document Team Lead.

Classification: Non-Exempt

Primary 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
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

Desired Skills and Qualifications:

• At least 6 months of medical experience.
• Ability to effectively lead a high-performance team
• Devote keen and acute attention to detail
• 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

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.