Centralized Study Associate Ii

6 days ago

Bengaluru, India Labcorp Full time

Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
- Maintains an understanding of applicable regulatory requirements.
- Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member
- Responsible for document classification under Smart Inbox (when applicable), ARC review, document deletion. TMF Classifiers or Start Up team members as part of the SSU Vault Model typically fulfill this role (TMF Classifier).
- Responsible for uploading documents and performing QC into Sponsor system if applicable.
- Maintains the TMF in a state of audit readiness for quality and compliance by:
Visual quality checks of e-documents prior to release to confirm image clarity and readability. Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;
- Comply with metrics established for performance.
- Process and track final essential artifacts required throughout all phases of the study in accordance with Labcorp SOPs, sponsor SOPs, GCP and ICH guidelines.
- Manages the identification of operational issues and resolutions related to the TMF.
- Responsible for gathering data requested by study team to support status reports to clients as per study requirements.
- Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.
- Participates in Client audits & Internal Audit as per study requirements.
- Collaborates with all members of BP&S.
- Ensures overall client satisfaction for all studies.
- Participates in business improvement initiatives to drive quality, productivity and continuous improvement of business processes.
- Maintains an understanding of applicable regulatory requirements.
- Attend internal or external study team meetings as required.
- Perform other related duties as assigned.
- Perform Training & Mentoring as required.

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