What are the responsibilities and job description for the Records and Translation Management Coordinator position at kps life?
KPS Life is hiring a Records and Translation Management Coordinator to be fully dedicated to one of our sponsor partners. This hybrid role requires 3 days per week onsite in either Warren, NJ or Armonk, NY.
We’re seeking candidates with basic knowledge of clinical trials and TMF management to support inspection preparation activities. Experience with Veeva Vault eTMF is preferred. If interested, please apply today!
Summary
The Records and Translation Management Coordinator is responsible for ensuring that clinical trial documentation is maintained in an audit- and inspection-ready state throughout the regulatory submission and approval lifecycle. This role performs proactive TMF assessments, coordinates remediation activities with cross-functional study teams, and provides operational support during health authority inspections. This individual will support the TMF Inspection Lead as a subject matter expert during health authority inspections.
Job Duties
We’re seeking candidates with basic knowledge of clinical trials and TMF management to support inspection preparation activities. Experience with Veeva Vault eTMF is preferred. If interested, please apply today!
Summary
The Records and Translation Management Coordinator is responsible for ensuring that clinical trial documentation is maintained in an audit- and inspection-ready state throughout the regulatory submission and approval lifecycle. This role performs proactive TMF assessments, coordinates remediation activities with cross-functional study teams, and provides operational support during health authority inspections. This individual will support the TMF Inspection Lead as a subject matter expert during health authority inspections.
Job Duties
- Consolidate stakeholder questionnaires to establish baseline TMF status and identify remediation priorities.
- Perform study-level TMF Inspection Preparation Program (TIPP) reviews, including review of essential document status, quality issue trends, site-level documentation, identified gaps, and TMF metrics.
- Consolidate and summarize TIPP findings into clear readiness updates for presentation to study teams.
- Coordinate kick-off meetings with clinical study teams and distribute TIPP findings to support Clinical Study Team action planning.
- Track and drive resolution of TMF documentation issues through closure in partnership with Clinical Study Leads, Functional Leads, and CRO contacts.
- Conduct targeted TIPP reviews for supplemental filings, resubmissions, and regional regulatory submissions; provide risk assessments and escalate critical findings as appropriate.
- Provide backend operational support during health authority inspections, including record retrieval, ad hoc report generation, and document package compilation.
- Support Quality Review and oversight activities for vendors from a TMF and Records Management perspective.
- Demonstrated, deep understanding of the CDISC TMF Reference Model, eTMF systems, and ICH-GCP guidelines.
- Demonstrated ability to prioritize and manage multiple projects simultaneously.
- Excellent communication skills (written and verbal).
- Highly self-motivated, flexible, and able to follow through in an ambiguous, fast-changing environment with a proven ability to meet deadlines under pressure.
- Highly organized and detail-oriented, with the ability to synthesize information and demonstrate strategic thinking.
- Highly proactive, flexible, curious, and resilient.
- Proficient in Microsoft Applications (Word, Excel, Project, and PowerPoint).