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.

CLINICAL TRIAL EXPERIENCE

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

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