Ramcharan Shiva Medidi
Trainee @Clinical Research Fastrack
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WORK HISTORY
Trainee @Clinical Research Fastrack
Rajahmundry, IN
ICH GCP E6 R (3) FDA Regulations 21CFR 11, 50, 54, 56, and the Common Rule 45CFR46 Data Management Informed Consent Process Clinical Trial Operations from feasibility through close-out GDP following ALCOA-C principles Identification and reporting of AEs and SAEs Quality Assurance, Monitoring, and Query Resolution Comprehension and Execution of Clinical Trial Protocols Maintaining a regulatory binder, housing essential documents, including but not limited to 1572, DOA, Training Logs, and other Investigator Site File (ISF) documents
EDUCATION
Great Eastern Medical School & Hospital
Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine
ABOUT RAMCHARAN SHIVA MEDIDI
Trained Clinical Research Professional with a strong medical background and hands on experience supporting patient care in high acuity clinical environments. Skilled in patient safety monitoring, interpreting clinical data and lab values, maintaining accurate EMR documentation, and following structured clinical protocols with consistency and attention to detail. Comfortable communicating in Telugu, Hindi, and English and experienced in working closely with multidisciplinary teams to support diverse patient needs.Completed comprehensive Clinical Research Training through Clinical Research Fastrack, gaining knowledge in FDA regulations, ICH GCP E6 R3, informed consent processes, AE and SAE identification and reporting, ALCOA C documentation standards, regulatory binder maintenance, and core clinical trial operations. Brings a patient centered mindset, strong clinical judgment, and disciplined documentation habits to research settings.Committed to contributing to high quality, ethically compliant clinical trials that support the development of effective treatments and improved outcomes for patients. Open to clinical research opportunities and fully prepared to integrate medical and clinical research training into supporting strong, reliable study execution.
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