- Conduction of qualification, initiation, monitoring, and closeout visits for research sites incompliance with the approved protocol.- Communication with the medical site staff including coordinators, clinical research physicians, and their site staff.- Verifying adequate Investigator qualifications, training, and resources, including facilities,laboratories, equipment, and staff.- Medical record and research source documentation verification against case report form data,including informing the site staff of any entry errors, ensuring good documentation practicesare being adhered to, and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.- Involvement in essential documents (Protocol, ISF, PIS, CRF) writing and finalization.- Verification that the Investigator is enrolling only eligible subjects as per study requirements.- Ensuring that the IMP is stored under appropriate protocol-specified conditions andthat accountability is maintained in-house and at the site.- Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting per the protocol and applicable regulatory requirements.- Identify issues in the project proactively and propose resolution; demonstrate ability toassess and problem-solve with assistance and escalates issues when appropriate.- Assessing the clinical research site’s patient recruitment and retention success and offeringsuggestions for improvement.- If required Contact to Sponsors – Telephonic contact as well as email.- If required able to resolve any CRO related queries of the Sponsor.- Building and maintaining site database.- Communication and relation management with vendors.

- Assists project managers in the production of study reports and updates.- Serves as an office-based point of contact for all sites during the course of the studyin addition to providing phone coverage for travelling team members.- Prepares investigator budget payments and distributes them to investigative sites.- Develops and maintains good working relationships with investigators and studystaff, serving as an ambassador to promote a high-quality and ethical image.- Facilitates project meetings with respect to the preparation and distribution ofmaterials and final meeting minutes, as well as the coordination of participants.- Assists with corporate administration activities according to need and availability.- Sets up and maintains the Trial Master File (TMF) in compliance with ICH GCP- Allocates space within the TMF room/area for all new Trials ensuring that the TMFindex is kept up to date.- Creates TMF folders as per the Project Manager’s instructions- Completes the Essential Document Tracker in a timely manner ensuring documentsare filed within the TMF upon receipt.- Prepares the TMF for return to sponsor.- Prepares the TMF for the archive as required.- Maintains the TMF room/area.- Performs other duties as assigned by management.

- Preparation for site selection visit.- IRB submission& approval.- Regulatory document collection.- Prepare the site for a Site Initiation Visit(SIV).- Assisting Principal Investigator in administering the Informed Consent Formprocess.- protocol adherence and compliance; to document protocol deviations asappropriate and communicate any impacting subject safety to the EthicsCommittee.- Pre-screening, screening, enrolling & recruiting subjects.- Creating and Preparing Source Documents and their templates.- Coordinate and schedule the subject’s regular follow-up visits & procedures,preventing lost to follow-up & missed visits. Maintaining regular contact withsubjects telephonically.- Manage Clinical Trial Materials (CTM), accountability, distribution & logistics atthe site.- Filling the case reports forms and electronic case report forms and resolving alldata queries within timelines.- Reporting and coordinating all Adverse Events & Serious Adverse Eventsaccording to their timelines.- Filling up and maintaining trial-related logs like drug dispensing logs. subjectlogs, Investigational Product Logs, and temperature logs. Etc.- Maintaining Calibration records of Instruments used for the trials.- Preparing Site for Monitoring & Audit visits, coordinating close out visit &Archival at the site.- Communicating all protocol-related issues and problems to the appropriatemanagement staff including but not limited to questions regarding the conductof clinical trials. Concerns regarding possible serious adverse events or subjectcompliance.- Attend Study related meetings as appropriate.- Co-ordinate Subject reimbursements.- Performing all the above activities in strict adherence to the InternationalConference of Harmonization (ICH) E6, Indian Good Clinical Practice (GCP).