Arjun J Email & Phone Number

Palakkad, Kl, In

India

South India

Collection of source data such as patient history , angiogram reports , discharge summary of patients for conducting retrospective study.Data entry of patients in excel sheet and QC checkCollection of essential documents such as CV& MRC and Protocol signature page from Principal Investigators for the retrospective study.Preparation of study presentation slides.Selection of suitable journals to publish the results of retrospective study.Site identification for prospective study.Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where requiredCarry out study drug/device administration procedures and documentation recordsTracking of used and unused stents from the siteProvide support to the Project Manager / Manager with ad-hoc tasks as requiredPreparation & maintenance of TMF and ISF documentsProject update reporting to Head of the Clinical DepartmentReview and collection of essential documents from the site for prospective study.Coordination with site staff and investigator for smooth conduct of the studyCoordination with different vendorsEnsure the protocol compliance

Kozhikode, Kerala, India

Documenting the study activities in compliance with ALCOA principlesScheduling and performing trail related activities and subject visits in compliance with protocolMaintain effective and on-going communication with the PI, Sponsor and research participants during the course of the study. Conduct clinical research studies under the supervision of the Principal Investigator.Support Principal Investigator to recruit and enrol the study subjects Assisting the Principal Investigator in voluntary consent process.Support Principal Investigator in screening the subjects as per protocol required inclusion and exclusion criteriaReporting adverse events and serious adverse events to all stake holders as per regulatory guide linesDemonstrating the subject about protocol and all the trial related procedures and requirementsPreparing for study start up, conduct and closeout Phase of a clinical trialEnsuring Protocol complianceMaintaining study specific files (ISF, Pharmacy binder, Source notes) and keeping it audit readyData entry and queries resolving in EDC as per sponsor time lineIP managementCoordinating with all stakeholders for ethics committee submissions and notificationsCoordination with different vendors for IP shipping , sample pick up and unused IP disposalTrain study subjects to use eDairies and other trail related devices and ensure complianceEnsuring the medical devices which are using in trails are calibrated and adequately documentedSupport Principal Investigator in performing and documenting the spirometer related proceduresShipping of patient samples as per the study requirements to central lab in compliance with protocol and lab manual.Maintained excellent rapport with the CRA by adhering to the protocol, regulatory and other requirements. Provide support to the CRA during monitoring visit and otherwise. Address the action items and respond within the agreed timelines.

Master'S Degree, Microbiology, General

Bachelor'S Degree, Microbiology, General