Research Regulatory Coordinator
New
United StatesFull-TimeMiddle
Salary25.19 - 44.31 USD per hour
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Job Details
- Required Skills
- GCPMicrosoft Office
Requirements
- High school education required.
- Bachelor’s degree in Biological Science, Social Sciences, English, or related field preferred.
- Prior clinical research experience preferred.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).
- Strong critical thinking, problem-solving, and organizational skills.
- Detail-oriented with ability to exercise independent judgment.
- Effective oral and written communication skills.
- Ability to manage conflicting priorities in a fast-paced environment.
- Valid state Driver’s License required for travel to satellite offices and meetings.
- Knowledge of Federal regulations, ICH, and GCP guidelines.
Responsibilities
- Collaborate with principal investigators and the clinical research team to prepare regulatory submissions and maintain files.
- Manage regulatory documentation for the Institutional Review Board (IRB), including initial submissions, continuing reports, amendments, and adverse event reporting.
- Maintain master regulatory files, including Delegation of Authority logs, FDA Form 1572, and investigator credentials, in accordance with SOPs.
- Support monitoring and audit activities by preparing regulatory binders and working with sponsors to resolve findings.
- Coordinate the archival of study documents for closed studies.
- Ensure documentation compliance using the ALCOAC method.
- Facilitate GCP and protocol-specific training for research staff and investigators.
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