AA2IT
TMF and Document Associate
AA2IT, Raleigh, North Carolina, United States, 27601
Title
- Clinical Trial Document SpecialistLocation
- Remote EST (Raleigh, NC preferred)Duration
- 6 monthsPay Rate
- $50/hrJob Summary
-Oversee the handling of clinical trial documents in the Trial Master File (TMF) by ensuring adherence to quality standards, regulatory requirements, and Standard Operating Procedures (SOPs)Responsibilities
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Maintain and foster working relationships and open communication between departmentsPrepare and inventory files for off-site storage, if applicableParticipate in TMF audits including preparation and follow-upPrepare inventories, assist with quality checks and reconciliation of files during the study and at study closureEnsure the security and compliance of all documents related to active and archived projectsReceive and inventory applicable project documents in the TMFProcess, scan, index, route and maintain applicable project documents for the TMF in accordance with quality standards and relevant SOPsDraft project specific TMF Plan and structure at the beginning of the trial as well as maintain and update TMF plan throughout the trialProvide ongoing training/feedback to the team on topics related to Good Documentation Practices (GDP), ICH-GCP, pertaining to TMF and document management per study team requirementsProvide study team reports or updates regarding status of TMF on a regular basisQualifications
-
Education in life sciences or medical health or other comparable professional qualificationsBachelor's degree in life science or medical health preferredExperience in document managementExperience in electronic trial master file (eTMF)Knowledge in clinical research and in the conduct of clinical trialsKnowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)Knowledge of Good Documentation Practices (GDP)Knowledge of the preparation and processing of documents for clinical trialsExcellent keyboard skills, with experience using Microsoft Office(Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reportsFlexibility and ability to support various clinical trials and teams in parallel
- Clinical Trial Document SpecialistLocation
- Remote EST (Raleigh, NC preferred)Duration
- 6 monthsPay Rate
- $50/hrJob Summary
-Oversee the handling of clinical trial documents in the Trial Master File (TMF) by ensuring adherence to quality standards, regulatory requirements, and Standard Operating Procedures (SOPs)Responsibilities
-
Maintain and foster working relationships and open communication between departmentsPrepare and inventory files for off-site storage, if applicableParticipate in TMF audits including preparation and follow-upPrepare inventories, assist with quality checks and reconciliation of files during the study and at study closureEnsure the security and compliance of all documents related to active and archived projectsReceive and inventory applicable project documents in the TMFProcess, scan, index, route and maintain applicable project documents for the TMF in accordance with quality standards and relevant SOPsDraft project specific TMF Plan and structure at the beginning of the trial as well as maintain and update TMF plan throughout the trialProvide ongoing training/feedback to the team on topics related to Good Documentation Practices (GDP), ICH-GCP, pertaining to TMF and document management per study team requirementsProvide study team reports or updates regarding status of TMF on a regular basisQualifications
-
Education in life sciences or medical health or other comparable professional qualificationsBachelor's degree in life science or medical health preferredExperience in document managementExperience in electronic trial master file (eTMF)Knowledge in clinical research and in the conduct of clinical trialsKnowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)Knowledge of Good Documentation Practices (GDP)Knowledge of the preparation and processing of documents for clinical trialsExcellent keyboard skills, with experience using Microsoft Office(Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reportsFlexibility and ability to support various clinical trials and teams in parallel