Clinical trial coordination assistant

• Aug 2023 - Present

Clinical Research Coordinator

• Jul 2021 - Jun 2022

Project Description: 1. Worked for Ampio Pharmaceutical INC for Phase II trial at JSS hospital, Pulmonology department, India. 2. Worked for IQVIA for Phase2/3, randomized, open label study at JSS Hospital, Paediatric department, India. 3. Worked as a part of team in Bharath hospital and Institute of oncology, India for cancer trials and trainee monitor for two months. Key Responsibilities: • Assisted with the development and review of study protocols, case report forms (CRFs), and informed consent forms (ICFs). • Coordinated and managed all aspects of clinical trials, including budget management, recruitment of study subjects, study visits, and study documentation. • Handling and reviewing of trial master and investigator site files. • Provided support and assistance in the coordination and overview of investigator site selection. • Assisted Risk management plan team by writing up the report. • Supporting the planning of corrective and preventative measures, audit preparation at the site. • Maintaining of electronic data base at site and reviewing, clarifying the queries during monitoring with Clinical research associate (Monitor). • Receiving, storage, temperature monitoring, dispensing and accountability of investigational medicinal product. • Oversees the training of the team in accordance with the study. • Maintaining inter personal communication with ethics committee, principal investigator, co-investigator, clinical research associates and subjects for hassle free trial operations at site. • Assisted the research team with the handling and archiving the documentation and reports at site level. • Assessing, identifying, and reporting Adverse drug reactions in clinical set up and in clinical trials. • Processing of Individual safety case report(ISCR) • Proper maintenance of investigator site file and source notes data. • Supported the site level activities with the senior coordinator. • Performing follow up calls to participants. Show less

Intern

• Nov 2021 - Dec 2021

1. Mixing of Chemotherapy drugs. 2. Providing patient counselling care about chemotherapy treatment. 3. Assisted oncology clinical trials. 1. Mixing of Chemotherapy drugs. 2. Providing patient counselling care about chemotherapy treatment. 3. Assisted oncology clinical trials.