Ankita Kohale

• · Receive Indexed documents and reviewed to finalize clinical trail documents, ensuring proper filing.
• · Performing quality checks on documents to ensure meet regulatory requirement and study protocols.
• · Maintain and update TMF according to established guidelines and best practice.
• · Track and manage document versions and ensure timely filing of essential documents.
• · Maintains of projects SLA as per documents submissions.
• · Prepare TMF inspection ready and audits.
• · Respond of internal queries from internal and external stakeholders as “Query Moderator”

• · Index documents in workflow and assign them to QC2.
• · Responsible for QC of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies. Answer Q&As in rooms within timeline.
• · Attend weekly meeting with PMs and discuss process and issues. Become expert in Trial Interactive features and functionality and work with PM and development team to improve TI.
• · Complete all other tasks that are deemed appropriate for my role and assigned by managers and leads.

· Conduction of Trial at site from initiation to close out.

· Identify potential patient by prescreening files of the patient coming from OPD and follow-up with the consultants.

· Help Principal Investigator for taking A/V informed consent.

· Coordination with the trial subjects and principal investigator.

· Coordination with local ethics committee for trial related documents submission and for their approvals.

· Maintain trial related all the logs.

· Filing case report form and eCRFs.

· Filing source documents.

· Conduction of patient follow ups.

· Coordinating with monitors during various visits of trial.

· Identification of AE/SAE and reporting to the sponsor and EC within the timeline.

· Keep track of study activities to make sure compliance with protocols and SOPs. Communicate with lab or researches about laboratory findings.