Records Specialist II

Premier Research

. Perform all departmental budgeted activities for assigned studies .

Posted 11/12/2026full-timeRemote • Spain, Bulgaria, RomaniaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trials records management, including proficiency in eTMF systems and compliance with ICH-GCP and ISO14155 regulations. Capable of effectively collaborating in a fast-paced environment while managing multiple priorities and deadlines.

Highest-signal resume keywords

Clinical Trials Records ManagementETMF System AdministrationICH-GCP KnowledgeISO14155 ComplianceWeb-Based Communication Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Records ManagementClinical Trials ExperienceETMF TechnologiesAudit AssistanceProcess Training

Soft Skills

Team CollaborationMultitaskingOrganizational SkillsTime ManagementEffective Communication

Tools & Technologies

ETMF SystemsComputerized Records Management TechnologiesWeb-Based Communication Tools

Industry Keywords

Trial Master File ManagementGlobal RegulationsCRO EnvironmentQuality Assurance

About the role

Key responsibilities & impact

Perform all departmental budgeted activities for assigned studies
Assist with identifying, reporting and resolving quality and efficiency concerns with records management work practices
Understand TMF Plans, TMF indexes and transition plans for assigned studies
Assist with live, web-based and/or recorded process and system training for company staff, Sponsors and/or third parties
Assist with internal and external audits and inspections globally for assigned studies
Assist with office-based and/or off-site corporate archives regionally as needed
Assist with system demonstrations, study KOMs and other targeted project team meetings globally
Assist with eTMF System Administrator responsibilities as needed
Perform additional duties assigned by the TMF Lead and/or department management

Requirements

What you’ll need

Successful experience and results as a Records Specialist I or equivalent in a clinical trials records management setting required
1+ years of clinical trials records management experience required; 2+ years without degree
Experience using computerized clinical trials records management technologies required
Global clinical trials experience preferred
Knowledge of web-based communication tools for conferences and other required IT systems
Knowledge of ICH-GCP, ISO14155 and global regulations pertaining to Trial Master File management
Excellent team player, collaborative and able to work within an effective team
Ability to multitask and work effectively and independently in a fast-paced CRO environment with changing priorities
Ability to read, write, and speak fluent English
Excellent organizational and time-management skills; ability to prioritize work to meet deadlines

Benefits

Comp & perks

Flexibility and balance to support your life requirements
Skills and opportunities for professional growth