John Obed Era
Bridgeport,CT
Summary
Experienced with clinical quality assurance and development of quality improvement strategies. Utilizes data analysis and regulatory knowledge to enhance healthcare outcomes. Strong understanding of process optimization and compliance standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Quality Specialist
Medical Research Center, CT
08.2024 - 09.2025
- Coordinate and manage clinical technology validation studies, ensuring adherence to GCP, FDA, and ISO 14155 standards.
- Lead operational planning, day-to-day management, and cross-functional coordination among engineering, legal, and product teams.
- Develop and manage data collection processes, electronic databases, and participant tracking systems to ensure accuracy and completeness.
- Handle IRB submissions and maintain documentation compliance with regulatory and institutional requirements.
- Implement best practices to streamline study setup, documentation, and site communication workflows, improving operational efficiency.
- Serve as a primary contact for research participants, vendors, and internal study leads to facilitate smooth trial operations.
Clinical Research Associate
Dr. Vince Clinical Research, CT
12.2023 - 04.2024
- Supported the execution of digital health and device studies, coordinating with CROs and sponsor teams.
- Conducted source data verification, monitored study timelines, and ensured compliance with study protocols.
- Worked closely with investigators to manage subject recruitment, retention strategies, and data resolution processes.
- Supported regulatory submissions, audit preparation, and communication with ethics committees.
- Facilitated staff training on study procedures and GCP compliance, promoting data accuracy and operational quality.
Clinical Quality Assistant
Apollo Hospitals, India
03.2020 - 07.2023
- Assisted in clinical study oversight, ensuring protocol adherence, ethical compliance, and accurate documentation.
- Collaborated with multidisciplinary clinical teams to enhance patient enrollment and data quality.
- Supported the preparation of regulatory and ethics submissions, maintaining timely reporting of adverse events.
- Contributed to pharmacovigilance documentation, safety monitoring, and CAPA implementation.
- Tracked quality metrics to support continuous process improvement across ongoing clinical programs.
Education
Master of Science - Healthcare Informatics
Sacred Heart University
Fairfield, CT12.2024
Doctor of Pharmacy - undefined
Osmania University
Hyderabad, India09.2022
Skills
- Clinical Research Management IRB Submissions Digital Health Studies
- Good Clinical Practice (GCP) ICH-GCP / ISO 14155 Regulatory Compliance
- CRO Collaboration Subject Recruitment & Retention Strategies
- Data Management: REDCap, Medidata, Excel, CTMS
- Cross-functional Communication Audit Readiness & CAPA Management
- Microsoft Office Suite Travel Flexibility up to 30%
- ISO 14155 standards
- Data management systems
- Clinical quality assurance
- Regulatory compliance
- GCP guidelines
- FDA regulations
- Study protocol adherence
- Electronic data capture
- Quality management systems
- IRB submission processes
- Adverse event reporting
Certification
- Licensed Clinical Pharmacist
- · Causality Assessment of case series- Uppsala Monitoring centre
- · Data Safety and Monitoring Boards for Clinical Trials - Global Health training centre.
- Introduction to Data Management For Clinical Research Studies- Global Health training centre.
- · Collecting high quality ADR reports.- Uppsala Monitoring centre
Timeline
Clinical Quality Specialist
Medical Research Center, CT
08.2024 - 09.2025
Clinical Research Associate
Dr. Vince Clinical Research, CT
12.2023 - 04.2024
Clinical Quality Assistant
Apollo Hospitals, India
03.2020 - 07.2023
Doctor of Pharmacy - undefined
Osmania University
Master of Science - Healthcare Informatics
Sacred Heart University