U. Kalyan Kumar

About U. Kalyan Kumar

Clinical Research professional with hands-on experience in Clinical Trial Operations and Site Coordination, supporting studies in compliance with ICH-GCP, SOPs, and regulatory guidelines.I have practical exposure to patient screening and enrollment, source documentation, EDC support, regulatory binder maintenance, adverse event reporting, and protocol compliance. My experience includes coordinating with Investigators, Sponsors, CRO teams, and Clinical Operations staff to ensure smooth trial execution.With a strong foundation in clinical research ethics, data integrity, and patient safety, I am eager to contribute to CRO or sponsor-driven clinical trials and grow into roles such as CRA, CTA, or Clinical Project Coordinator.Core Interests: Clinical Trials | Site Operations | Monitoring Support | Regulatory Affairs | Data Quality

Experience

1. Clinical Research Coordinator

   Clinispace Solutions Pvt Ltd

   May 2025 — Present · Hyderabad, IN

   Coordinated multiple clinical trials across diverse therapeutic areas including Pediatrics (Vaccines), Pulmonology (COPD, Asthma), Post surgery wireless Device Study (Arrhythmias), Orthopedics, Dermatology, and Real World Evidence (RWE) studies•Hands-on involvement in study start-up activities, including trial initiation, site preparation, and Ethics Committee (EC) submissions•Successfully managed patient screening, recruitment, and follow-up visits while ensuring protocol compliance•Conducted Informed Consent Process (ICF consent) with high adherence to ethical and regulatory standards•Maintained accurate source documentation, CRF/eCRF data entry, and ensured data integrity•Assisted in AE/SAE reporting, safety follow-ups, and documentation as per regulatory timelines•Supported monitoring visits (on-site & remote) and ensured audit readiness with proper documentation•Maintained and organized Site Master File (SMF) and essential regulatory documents• Tracked patient visits, study logs, and trial progress using structured trackers•Ensured compliance with ICH-GCP guidelines, SOPs, and protocol requirements•Coordinated effectively with Investigators, CRAs, Sponsors, and Ethics Committees •Demonstrated strong attention to detail, time management, and multi-tasking abilities in a fast-paced clinical research environment•Contributed to audit readiness with zero major findings, ensuring complete and compliant documentation as per ICH-GCP guidelines• Efficiently managed multiple concurrent clinical trials, maintaining timelines, data quality, and coordination across study teams•Supported site feasibility activities, including collection of site capabilities, patient pool assessment, and coordination with the study team•Regularly followed up with Principal Investigators (PI) for study-related updates, approvals, and documentation requirements

Education

• SVMVSR junior college

  Intermediate , BIPC

• St.Anne's English Medium School

  SSC

• Santiram medical college & General hospital.

  Clinical pharmacist internship

• Santhiram college of pharmacy

  Doctor of Pharmacy - Pharm.D, Doctor