Anitha Reddy Peram
Hackensack,New Jersey
Summary
Dedicated and detail oriented Clinical Research Coordinator with experience in managing and overseeing clinical trials, ensuring strict compliance with GCP, FDA, Investigational product accountability and ICH regulations and effectively coordinating with study protocols, data collection and participant recruitment to achieve successful trial outcomes.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Washington University School of Medicine
03.2025 - 10.2025
- Coordinated participant recruitment and screening for clinical trials by closely working with patients.
- Managed clinical trial documentation and ensured compliance with institutional policies.
- Assisted in data collection and maintained accurate study records.
- Collected and managed patient information, health histories ensuring timely data entry into EDC systems
- Managed investigational drug accountability logs.
- Attended weekly meetings with principal investigators and research team members to discuss project updates.
Manufacturing Intern
DARWIN FORMULATIONS PRIVATE LIMITED
05.2022 - 07.2022
- Adhered to Current Good Manufacturing Practices (cGMPs) to maintain high standards of product quality and safety throughout the manufacturing process.
- Experienced in Verifying that all processes align with Good Clinical Practices (GCP), particularly for products undergoing clinical trials.
- Experienced in Analyzing test data and preparing detailed reports for management, highlighting any quality issues and recommending corrective actions.
- Conducted literature reviews and synthesized findings to support clinical research objectives.
- Collaborated with teams to ensure adherence to GCP and ethical standards.
Regulatory Affairs Intern
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
06.2021 - 12.2021
- I have gained the knowledge about different regulatory governing bodies like CDSCO, USFDA, TGA, PMDA, HEALTH CANADA and followed procedures based on ICH guidelines.
- Gained proficiency in preclinical study and the clinical trials and various phases of clinical trials and how they conduct the clinical trials.
Education
Masters - Healthcare Informatics
Sacred Heart University
Fairfield, CT, USBachelors - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
Guntur, IndiaSkills
- EDC
- EPIC EMR
- GCP Regulations
- Microsoft Office
- Regulatory Standards
- Analytical Tools
- CTMS
Certification
- Good Clinical Practice - CITI
- Registered Pharmacist
Timeline
Clinical Research Coordinator
Washington University School of Medicine
03.2025 - 10.2025
Manufacturing Intern
DARWIN FORMULATIONS PRIVATE LIMITED
05.2022 - 07.2022
Regulatory Affairs Intern
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
06.2021 - 12.2021
Bachelors - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
Masters - Healthcare Informatics
Sacred Heart University