Source Document Specialist
Alliance For MultiSpecialty Research LLC
Summary
The role of the Source Document Specialist is responsible for creating and maintaining study source documents throughout assigned studies.
Job description
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
- Fluent in English.
Requirements
- 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
- Fluent in English
Company overview
Alliance for Multispecialty Research LLC, operating as AMR Clinical, is a leading clinical research organization founded in 1994 and headquartered in Knoxville, Tennessee. With over 30 years of experience in the clinical research industry, AMR Clinical has established itself as a premier provider of clinical trial services across all phases (I-IV) of drug development. The company operates a network of 32 fully-owned and affiliate research centers across the United States, specializing in a broad range of therapeutic areas including cardiology, dermatology, endocrinology, vaccines, and more. AMR Clinical has successfully conducted more than 7,700 clinical trials and enrolled over 145,000 participants, demonstrating extensive expertise in patient recruitment and trial execution. The organization employs approximately 400 professionals and generates around $21 million in annual revenue. As a private equity-backed company, AMR Clinical focuses on delivering high-quality data, consistent patient recruitment, and accelerated drug development timelines through its centralized, integrated infrastructure that ensures protocol adherence and reliable data quality across all locations.