Melvin Moses Banja

Toledo

Summary

Experienced clinical research professional skilled in coordinating patient-oriented studies, managing regulatory submissions, and ensuring compliance with IRB and FDA regulations. Proven success in supporting multi-site investigator-initiated trials, recruiting subjects, and maintaining data integrity. Proficient in REDCap and TMF systems, with a talent for fostering collaborative work across research institutions.

Overview

years of professional experience

Certification

Work History

Clinical Research Coordinator– Pharmacovigilance & Clinical Data Management

Dr. Reddy’s Laboratories

01.2021 - 12.2023

- Coordinated regulatory documents, tracked site communications, and assisted with protocol compliance for multi-site trials.
- Recruited participants, scheduled and documented virtual and in-person study visits, and maintained subject data logs.
- Assisted with the preparation and submission of IRB documentation including initial applications, amendments, and adverse event reports.
- Collaborated with physicians and research staff to track enrollment, specimen handling, and subject follow-ups.
- Supported the setup and audit-readiness of Trial Master Files (TMFs), REDCap databases, and CTMS entries.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

Education

M.S.B.S. - Clinical Research

The University of Toledo

Toledo, OH

Skills

Patient Recruitment Informed Consent Visit Coordination
IRB Submissions Protocol Amendments Regulatory Compliance
REDCap CTMS TMF Systems Multi-site Collaboration
Good clinical practices

Electronic data capture
Documentation management
Adverse event reporting