Brief description :
Job Title: Clinical Trial Associate
Job Location: Trivandrum, India
The Clinical Trial Associate will support and work closely with the global project team including internal and external customers and suppliers through all phases of the study. Duties may include coordination, or ADI Log maintenance, data entry, tracking, scanning, copying, creating, maintaining and QC of essential documents and Trial Master Files. Meets defined chargeability expectations for position.
Job Duties and Responsibilities:
- Assists with conduct of site feasibility and associated tracking.
- Coordinates the distribution and collection of site start up packets and essential documents. Tracks appropriately.
- Communicates project status and provides associated reports to the project team as appropriate.
- Assists in the retrieval and resolution of issues with transmittals.
- Scans and copies project documentation inclusive of, but not limited to, essential documents, CSAs, CRFs, and DCFs.
- Reviews deliverable to ensure accuracy of content and materials copied.
- May Support the project team in preparation of documentation for Regulatory and Ethical Submissions.
- Organizes study documents and materials in compliance with Project and/or Sponsor SOPs as appropriate.
- Archives study documentation and works with IT to return the TMF to sponsor, as directed.
- Reports all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis
- Establishes the Trial Master File / eTMF in accordance with project, organisational and regulatory requirements.
- Maintains the Trial Master File / e TMF as required by the study plans
- Files according to Clinipace SOPs and/or Sponsor requirements along with Clinipace quality standards and adhere to 98% accuracy across the major files sections and the documents contained therein.
- Forwards correspondence to sites, sponsors and project teams as needed.
- Interfaces with vendors as required for a project.
- Provides support to the team communicating process improvement suggestions as applicable.
- Resolves administrative issues on behalf of the Project Manager.
- Review and maintain study Outlook folders.
- Maintains project server and portal where applicable
- Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently
- Assists with final site TMF review and Close Out Visit reconciliation packets. Communicate findings and provide packs to CRAs.
- Other duties as assigned by SMS Team Lead or Project Manager/SMS Director and per project-specific requirements
- Healthcare or life science degree is a plus Equivalent relevant work experience considered.
- Prior work experience preferred
- Strong English language written and verbal communication skills
- Strong interpersonal skills
- Team-oriented and a strong team player
- Strong computer skills, including Microsoft Office
- Interest in learning medical terminology
- Exceptional attention to detail