Records Information Associate

1 week ago

Thiruvananthapuram, India Caidya Full time

**Job Title**:Records Information Associate

**Job Location: Trivandrum, Kerala**

**Job Overview**:
The Records Information Associate, in collaboration with global internal and external study team members, supports all phases of the study under departmental and/or study team supervision. Duties may include Trial Master File (TMF) processing, inclusive of essential document review, such as tracking, maintaining, collecting, and coordinating content. Supports multiple studies based on scope. Meets defined chargeability expectations for position.

**Job Duties and Responsibilities**:

- Manages the set-up and maintenance of General, Country and Site level artifacts within electronic TMFs in accordance with Clinipace processes and study-specific plans
- Supports regulatory inspections and/or audits as required
- Reports all document collection and tracking issues to Records Information Management Team Lead and/or study team on a routine basis
- Proactively identifies, manages, escalates (as needed) and resolves document issues effectively and independently
- Assists with final site TMF review and Close Out Visit reconciliation - communicates findings and provides feedback to applicable study team member(s)
- Assists with study plan and core document reconciliation as required
- Archives study documentation and works with IT to return TMF to sponsor as directed
- Prepares and provides associated reports to study teams as applicable
- Collects, tracks (as applicable), and maintains study team training records under Project Manager oversight
- Ensures all training plan versions and training records are filed in TMF
- Reviews, creates subfolders (as applicable), and maintains project mailboxes
- Conducts and documents Food and Drug Administration debarment, disqualified, and inspection lists as requested
- Files according to Clinipace processes and/or sponsor requirements along with Clinipace quality standards adhering to

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