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Global Records Mgmt Associate - Fsp

1-3 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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