Dinesh Kumar Joshi

· Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.

· Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.

· Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.

· Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

· Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

· Inform patients or caregivers about study aspects and outcomes to be expected.

· Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

· Overseeing the smooth running of clinical trials.

· Informing participants about study objectives.

· Administering questionnaires.

· Monitoring research participants to ensure adherence to study rules.

· Adhering to research regulatory standards.

· Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation.

· Participating in subject recruitment efforts.

· Ensuring that the necessary supplies and equipment for a study are in stock and in working order.

· To handle all type of production work, coordinate and oversee the production process to ensure that the production meet quality specification

· Implement quality control measures during the production to prevent any defect and to the final product compliance with regulatory standards

· Performing IPQA in production area

· Performing all type of test in lab like Finished product, Semi-finished, Raw material to ensure the quality of product

· Command in handling all type lab instrument

· Comprehensive knowledge of computer, data entry like BMR,MIN, PR, GRN in excel production and laboratory

• Maintained open lines of communication with parents, fostering strong partnerships to support student success.
• Improved student literacy by implementing targeted reading strategies in daily lessons.
• Contributed to the development of school-wide initiatives aimed at improving overall student achievement levels.
• Developed critical thinking skills in students through problem-solving activities and real-world applications of concepts.
• Collaborated with colleagues to develop interdisciplinary lesson plans that connected subject matter across various disciplines.