Build Your Career at
Veeda Lifesciences

Name

:

Deepak Joshi

Functional Designation

:

Project Coordinator

Department

:

Clinical Research

Reporting to

:

Group Leader- Project Coordinator

Location

:

Shivalik, Ahmadabad, India.

Qualifications

:

Bachelor of Pharmacy

Experience

:

27 Days

Special Skills

:

1. Attitude – Ever Positive
2. Excellent coordinating capability

3. Willingness To Learning

Sr. No.

Job Responsibilities

Ensure following are available before study execution:

• No Objection Certificate (NOC) from regulatory authority
• Approval letter from the IEC
• Availability of Investigational Product (IPs) at site

Study Planning and Execution:

• Coordinate with the Principal Investigator / Project Manager for planning of study schedule.
• Prepare Trial master file as per the SOP or Sponsor’s requirement.
• Prepare the protocol summary for the protocol training.
• Ensure that the protocol training is provided to the concerned study personnel, before the start of study related activities.
• Coordinate with screening team for subject recruitment and screening.
• Coordinate with Dietician to ensure that the meal menu is prepared as per protocol requirements and submitted to caterer well in advance.
• Ensure that all the volunteers reported for ICD presentation are fit for participation in the study as per the respective protocol.
• Coordinate with Principal Investigator and / or Clinical Investigator and / or clinical research physician for ICD presentation to subjects
• Coordinate with clinical staff for admission, discharge, Meal distribution, dosing/dosing supervision and monitoring the subjects during study for restriction compliance.
• Ensure that the biological samples are collected, processed, stored and transferred as mentioned in the protocol. Review all forms and log formats related to the processing, storing and transferring of the samples.
• Ensure that the adverse event/serious adverse event reported during the study are adequately handled.
• Monitor the study to ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and in house Standard Operating Procedures (SOP).
• Collect and review the raw data from group leaders (e.g. Nurse, Phlebotomist, and CRP etc) and handover those to CQMs for their review.
• Coordinate with the CQM for submission of raw data and draft project report to the QA department as per the predefine timeline.
• Coordinate with the CQM and QA for audit reports and compilation.
• Coordinate with Report writer and Project Manager for preparation of the final report.
• Coordinate with the PI/CI and PM for submission of CRFs to the Data Management and resolve all the data queries, if applicable.

Regulatory/Client Audit or Visit:

• Ensure all the study documents are available as per the TMF checklist for audit.
• Ensure the respective clinic/facility is ready for audit/visit.

Archival:

• Coordinate with PM and CQM for Archival of study documents (e.g. Protocol, project report, study raw data and other documents) and mail /telephone communication as per the procedure.

Others:

• Identify protocol deviations, SOP deviations, and file notes in consultation with the PI/CI/PM.
• Coordinate with PM / Head CPU for preparation of new SOPs as well as revising current SOPs to upgrade the system.
• Perform any other duties as assigned by Principal Investigator / Project Manager.

• Handling of Investigational products (i.e. Receipt, Storage, Accountability, and Disposal).

• Compounding and dispensing of Investigational Products as per Randomization schedule and Protocol.

• Coordinate with Principal Investigator for maintaining accountability of investigational product up to retention period.

• Management of Pharmacy.

Employee’s Signature

Authorized by

Name

Mr. Deepak Joshi

Mr. Amit Thummar

Designation

Project Coordinator

Group Leader-Project Coordinator

Signature

Date

VIN-HRD-FT016-03(VIN-HRD-004-03)

Page 1 of 3