Dr. Prachi Barot

• Negotiate study budgets with investigators and ensure that timely payments are made to the site as per guidance from Project Manager
• To provide training to site study team regarding the monitoring plan, recording & Maintenance of essential documents and for startup activities & site initiation as per the guidance of Project Manager
• Assist for the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures
• Conduct of monitoring visits as per monitoring plan to check compliance with study management, protocol & other requirements at all assigned sites
• Maintaining a working copy of Central Investigator File & ensuring consistency with the Site Investigator File to maintain a working record of all essential documents and reports.
• Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up to date & maintained according to applicable SOP's to avoid incomplete records
• Ensure timely collection of documents like CRF,DCF etc from the site along with SAE reports to provide Biometrics/licensing authority & others with the necessary documents
• To provide study updates & Coordination with Labs & other trial related services as per the study requirements
• To verify & track IP accountability and availability
• Ensure proper escalation of site/project related issues to Project Manager/ Designee in a timely manner.
• Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP and applicable regulatory guidelines.
• Ensure to follow and adherence of organization's general rules, policies, and applicable SOPs.

To identify & collect necessary documents for the Site Monitor/ Project Manager/ designee, to check the feasibility of site/ investigator and approval from authorities.
 To assist PM during preparation of study related Plans

 To Prepare study related Logs & Forms.
 To attend all study-related meetings with sponsor & different stockholders.
 To prepare minutes of meeting of the study related meetings.
 To coordinate with different departments for timely execution of the study related activity.
 To maintain study related trackers, precise tracking of subject visits,  IP accountability, Instrument tracking, sample collection tracking, lab reports tracking, assist CRA for Monitoring visits & report tracking, Tracking of EC related documents, Tracking of PD & AE filing.
 Faced internal QA audit of eTMF, eCIF & assisted PM to finalize eTMF QA audit response.
 To prepare study updates, weekly meeting & Global meeting presentations.
 To prepare regulatory annual study report of study for the regulatory submission.

 Maintaining the study specific e-folders as per the study requirements.
 To resolve the Queries of eTMF/eCIF related document
 To track site specific available study material & Provide Study supply to the sites.
 To coordinate with CRAs & site team for day-to- day study related activity.
 To archive the study.

• Assist in collection of necessary documents to be forwarded to Project Manager/ designee
• Assist in reconciliation of essential documents
• Assist in the preparation and presentation for training purposes
• Assist in maintaining Trial Master Files
• Assist to prepare Site Master file
• Assist to Prepare EC Dossier & Regulatory dossier
• Assist in preparation of study updates
• Attend meetings and training sessions as required
• QC of all the study documents
• Reviewing IP release checklist documentation & to provide appropriate response to QA team with regards to observation
• Assist in study start up activity, collection of feasibility of the site. EC submission & approval activity.