Global Records Management Associate – FSP (Onsite, Indianapolis, IN)
Job ID: R-01331793
Category: Clinical Research
Employment Type: Full-Time
Work Model: Fully Onsite
About the Opportunity
ThePharmaDaily.com is pleased to feature a key operational role for a Global Records Management Associate (FSP Model), supporting a leading global CRO through an onsite position in Indianapolis, Indiana. This role provides essential administrative and technical support to ensure documentation integrity across clinical research activities, spanning feasibility, study start-up, trial maintenance, close-out, and database lock.
As part of a client-dedicated Functional Service Partnership (FSP), you will be embedded within the sponsor’s organization to manage critical clinical trial records and compliance processes.
Role Summary
This position oversees the daily operations of the Records Center, managing the full lifecycle of clinical research documents—both electronic and paper-based. The role requires strong organization, attention to detail, and the ability to handle multiple priorities in a regulated environment. Candidates must be capable of lifting up to 40 lbs and navigating a fast-paced administrative setting.
Location: Greenwood, Indiana
Relocation: Not available
Key Responsibilities
Document & Records Management
Manage incoming and outgoing research source documents, including submissions, retrievals, and controlled transfer processes.
Create, maintain, and update tracking tools for documentation workflows.
Process electronic documents, moving files across designated storage systems.
Convert paper documents to electronic format and upload to appropriate repositories.
Verify that all documents are correctly indexed, uploaded, and true-copy certified.
Quality & Compliance
Perform quality control checks on all documentation handled.
Maintain data accuracy, integrity, and compliance with study-defined requirements.
Ensure work processes align with GCP and GDP guidelines.
Cross-Functional Coordination
Retrieve and organize source documents from Central Study Coordinators.
Sort, file, and archive documents according to standard operating procedures.
Prioritize daily tasks based on study needs and timelines.
Collaborate with internal teams to support efficient document lifecycle management.
General Administrative Support
Execute daily operational activities within the Records Center.
Support project-based initiatives as assigned.
Follow written and verbal instructions accurately while maintaining a high level of productivity.
Skills and Competencies
Strong verbal and written communication skills
Ability to prioritize, organize, and multi-task effectively
Proficient in Microsoft Word and Excel
Knowledge of record management processes
Strong attention to detail
Problem-solving and self-management skills
Flexibility to adapt to shifting priorities
Understanding of GCP/GDP (preferred)
Education and Experience Required
Education
High/Secondary School Diploma or equivalent
Formal academic/vocational qualification preferred
Experience Required
1–3 years of experience in records management, document control, administrative support, or similar roles
Experience in clinical research, pharmaceuticals, or CRO environments is preferred
Proficiency in computer systems and digital documentation tools
Experience working with regulated documentation is an advantage
Physical & Work Environment Requirements
Ability to stand or remain stationary for extended periods
Ability to lift up to 40 lbs
Comfortable using standard office equipment and technology
Ability to work under pressure and manage multiple tasks
Some travel may be required based on project needs
Gujarat :
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