Dileep Kumar Devanga Email & Phone Number

Hyderabad, Telangana, India

Hyderabad Area, India

Delhi Area, India

• Coordinate with study monitor during the site selection, initiation, routine monitoring visits and site close out visit activities• Developing, implementing and maintaining study documents, timelines, files, communication tools, and systems used in conducting a project.• Maintain the study related Logs and Forms: Screening, Enrolment, Drug Accountability, Temperature and other communication logs.• Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.• Screening, Enrolment, Drug Accountability, Temperature and other communication logs.• Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.• Assist the investigating team in the process of administering the informed consent to subjects and explain in details about the patient information sheet & patient diaries.• Coordinate Screening and recruitment of patients based on protocol eligibility criteria. Coordinate all patient-related appointments.• Maintain subject related source documents like Visit notes, Medical history, laboratory Investigations, ECG reports and other documents (all signed and Dated by Investigator or Designee) as required in the Protocol.• Expertise in handling “e-systems” of clinical trials like eCRF (Inform 4.6 Version), IWRS (ClinPhone&Cenduit).• Perform data entry into EDC within timelines specified by sponsor (within 48 hours of subject follow up visit). Resolve Data Clarification Forms in consultation with the investigator.• Updating and maintaining the Investigator Site File and sending progress reports to CRO.

Chennai Area, India

• Site initiation,continuation and close out • Assist with the preparation of IRB applications, including protocol &informed consents & obtain approval to conduct the study.• Tracking & maintaining the study budget & payments, including invoicing the sponsor for completed work• Coordinating with Patients and getting medical history and forwarding to sponsor along with patient identification forms.• Coordinating with CRO uploading CT scan images to CRO web mail along with imaginary transition form• Forwarding CT scan reports to sponsor for getting approval for screening the subjects• Performing screen tests to all eligible subjects according to the sponsor requirements• • Preparation and maintenance of source document• Proper handling of IP shipment and storage maintaining the temperature logs & Drug accountability logs• Coordinating with radiology dept Regarding patient eligibility RECIST guidelines 1.1 (accordingly)• To Monitor and ensure that study is conducted as per Protocol, ICH-GCP guidelines. schedule Y and concerned regulatory authorities• Filling Feasibilities• Screening of Patients in various Trials according to the protocol.• Monitor health &safety of subjects with frequent contact & ensure subject compliance with the study• Completion of paper CRF & Electronic-CRF• IP Accountability& IP Dispensing • Follow up with pathological lab reports & Maintain required records of study activity including case report forms, drug dispensation records. • Maintaining patient related data confidentially (HIPPA GUIDELINES) Accordingly and trial data documentation& Archival• coordination with PI & clinical study staff & patients & local and central lab departments• Coordinating with PI, SPONSOR, and ethics committee. regarding AE & SAE occurred at site • Patient recruitment, randomization, treating with IP, and patient follow up. Tracking subjects, avoiding lost-to-follow-up•

Chennai Area, India

• Recruiting subjects, Screening and scheduling subjects ,Getting voluntary subject consent &Teaching subjects about protocol expectations for them.• Subject follow up from visit 1 to end of the treatment.• Processing and shipping lab work and documenting the all lab report accordingly good document practice• Preparation and maintenance of source document• Completion of paper CRF & Electronic-CRF• IP Accountability& IP Dispensing • Communicating with IRB and reporting AE’S • Documentation of study related activities and and submitting data for sponsor requirements • Submitting Regulatory documents to IRB & Sponsor

Master'S Degree, Clinical Research & Experimental Medicine, 8

Activities and Societies: *participated as volunteer for Advanced workshop on bioavailaility&Bioequivalence studies at CHRI *participated.

Master'S Degree, Organic Chemistry

Bachelor'S Degree, Biotechnology