Sandeep Kumar

I am Seeking a challenging career in Clinical Research where I can utilize my academic, technical and analytical knowledge and significantly contribute to the growth of the organization with hard work and dedication.

• Pediatric (Respiratory Syncytial Virus), III Phase, Clinical Research Associate
• Cholera Infectious Disease, III Phase, Clinical Research Associate
• Virology (Covid-19), III Phase, Clinical Research Associate
• Tibrolin (Wound Healing & Pain Management), IV Phase, Clinical Research Associate
• Diabetes Mellitus (Macro vascular & Micro vascular), IV Phase, Site Monitor
• Dermatology (Acne Vulgaris), III Phase, Site Monitor
• Oncology: Non-Small Cell Lung Cancer, III Phase, Clinical Research Coordinator
• Oncology: Hepatocellular Carcinoma, III Phase, Clinical Research Coordinator

• Sanofi Pasteur, USA
• International Vaccine Institute, South Korea
• PPD Singapore, Nepal
• Croissance Clinical Research, Hyderabad, Telangana, 08/2021, Present
• Tech Observer India Pvt Ltd, Bangalore, Karnataka, 04/2019, 08/2022
• Shree Venkateshwra Hospital, Bangalore, Karnataka, 04/2018, 04/2019

• Passport Number: P6694768
• Title: Senior Clinical Research Associate
• Date of Birth: 04/06/1992

• Responsible for the Site selection, site qualification, and documents collection
• Collects documents needed to initiate the study and submit it to the sponsor.
• To organize interdepartmental meetings regarding the study.
• Responsible for Site Initiation, Interim Monitoring visits, and Site Closeout Visits.
• Maintains adequate inventory of study supplies, stationaries and ISF and handling investigational drugs/devices, follows the sponsor protocol.
• Reviewing essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate, current, and identical to Trial Master File (TMF)
• Responsible for the communication between sponsor and sites
• Responsible for the preparation of SIV Confirmation letter, Checklist, Report and Follow up letter
• Responsible for the preparation of SMV Confirmation letter, Report and Follow up letter
• Facilitating escalation processes for elevating site or study issues in clinical monitoring with monitored reports for study site personnel and team members
• To inform the screening team to organize the screening of volunteers as per inclusion and exclusion criteria
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Ensured study documentation is completely and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations
• Thoroughly communicating with principal investigators and their staff members to resolve the queries
• Assisting in on-site monitoring of clinical trials including review of source documentation, case report forms, regulatory materials, and drug accountability.
• Responsible for the preparation of SCV Confirmation letter, Checklist, Report, and Follow up letter
• Monitoring the participants to ensure that adherence to the study rules and regulatory standards
• Provides appropriate training and tools for site study team members.
• Providing timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB.
• Works with the PI to develop and implement recruitment strategies in accordance with Sponsor requirements and approvals.
• Review of screened subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• To assure that CRF/eCRF are completed.
• Responsible for source data verification.
• Monitoring the data on EDC tools and query raise.
• Resolution of queries, clinical findings and observations and quality of data produce
• Review of the ICF/ISF, source notes, facility etc.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms/eCRF.
• Protocol and protocol amendments training
• To assist PI/Site for AE/SAE reporting and follow up, file protocol deviations and violations.
• To write and revise SOPs as per need and maintain awareness and adherence to all current SOPs.
• Responsible for review of drug accountability, study documents archival post completion of the study
• Assist the PI in the submission of accurate and timely closeout documents to the applicable IRC/IEC and applicable regulatory

• English
• Hindi

Clinical research and Data Management, Clini India Institute, Bangalore, 07/2017, 12/2017

I hereby declare that the above mentioned information by me is true to the best of my knowledge and belief. If selected I assure that I would perform to the best of my abilities with exemplary professional approach to reach up to the organization expectations.