Clinical Research Trial
Resume:
Shiva Kumar
Email: ****************@*****.***
Mobile: +1-781-***-****
Address: Massachusetts, United States
Professional Summary
Experienced Clinical Research Coordinator (CRC) with 3+ years of expertise in clinical trial management, regulatory compliance, and data coordination.
Skilled in data collection, quality control, and electronic data capture (EDC) systems, ensuring accuracy and integrity in clinical trials.
Proficient in multi-therapeutic area research, including Oncology, Cardiology, Dermatology, and Infectious Diseases.
Strong background in IRB submissions, protocol implementation, and research billing compliance.
Experienced in clinical data management, regulatory documentation, and manuscript writing for research publications.
Effective communicator with the ability to collaborate with Principal Investigators (PIs), clinical teams, and regulatory bodies.
Proven ability to train and mentor research staff, ensuring compliance with clinical research policies and quality audits.
Therapeutic Areas
Clinical Trial Coordination & Data Management
Regulatory Compliance & IRB Submissions
Multi-Therapeutic Research: Oncology, Cardiology, Dermatology, Infectious Diseases
Protocol Implementation & Study Monitoring
Electronic Data Capture (EDC) & Research Billing Compliance
Training & Quality Audits
Work Experience
Clinical Research Coordinator – Clinical Trial & Data Management
New England College, Concord, NH
June 2023 – Nov 2024
Managed clinical trial data collection, quality control, and compliance with GCP, ICH, and FDA regulations.
Conducted site monitoring and risk-based monitoring, ensuring data accuracy and protocol adherence.
Developed and maintained research study budgets, ensuring compliance with research billing requirements.
Completed IRB submissions, regulatory reporting, and protocol amendments, ensuring proper documentation.
Led data entry and validation using EDC systems (Medidata Rave, Veeva Vault, REDCap), ensuring real-time data accuracy.
Coordinated multi-phase clinical trials by liaising with PIs, clinical managers, and pharmacy teams.
Provided training and mentorship to junior research staff on data integrity, regulatory compliance, and study protocols.
Clinical Research Coordinator – Multi-Therapeutic Area Trials
Care Hospital, Hyderabad, India
Feb 2019 – Aug 2022
Led data coordination and clinical research trials in Oncology, Cardiology, Dermatology, and Infectious Diseases.
Performed remote and on-site monitoring visits (pre-study, initiation, routine, and close-out) to ensure compliance with FDA, ICH, and GCP standards.
Managed clinical trial documentation, IRB submissions, and data integrity checks for multiple research studies.
Handled drug accountability, patient safety monitoring, and adverse event (AE) reporting, ensuring regulatory compliance.
Analyzed clinical data trends and generated reports for study sponsors and investigators.
Assisted in financial tracking and study budget preparation, ensuring research billing compliance.
Trained research staff and site personnel in study protocols, data entry procedures, and compliance guidelines.
Key Skills
Clinical Trial Data Coordination & Quality Control
Electronic Data Capture (EDC) & Clinical Data Management
Regulatory Compliance & IRB Submissions
Oncology, Cardiology, Dermatology, & Infectious Disease Research
Risk-Based Monitoring & Adverse Event (AE) Reporting
Protocol Implementation & Research Billing Compliance
Training & Mentorship of Research Staff
Multi-Departmental Collaboration & Study Monitoring
Education
New England College, Concord, NH
Master of Science (MS) in Health Informatics
Jan 2023 – May 2024
Osmania University, Hyderabad, India
Bachelor of Science (B.Sc.) in Life Sciences
Jun 2015 – Mar 2018
Certifications & Training
Good Clinical Practice (GCP) Certification
Clinical Research Coordinator (CRC) Training – Completed
Clinical Research Associate (CRA) Training – Completed
Clinical Research Training Certification
IRB Compliance & Regulatory Training
Proficiency in Research Billing & Data Management
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