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Regulatory Coordinator
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Segal Institute for Clinical Research
North Miami, FL (In Person)
Full-Time
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Job Description
Regulatory Coordinator Segal Institute for Clinical Research
- 4.
Full Job Description Position Summary:
The Regulatory Coordinator completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance. Assists Regulatory Manager and study staff as delegated by the Regulatory Manager or Director of Quality Assurance.Essential Job Duties:
1. Notify administration, regulatory, recruitment, and study team including PI upon receipt and submission of regulatory documents 2. Request answers to questions from CRO/Sponsor (see attachment) prior to completion of documents 3. Ensure regulatory documents are filed in the Clinical Trial Management System (CTMS) prior to site activation and update Regulatory Checklist, as applicable 4. Obtain study advertising materials from other studies with same indication and submit to advertising director for approval prior to submission of initial regulatory document 5. Obtain subject stipend/compensation from contract department 8. Review initial IRB approved consent form to ensure accurate information such as site address (if applicable), office and emergency phone numbers, and compensation 6. Maintain and update binders throughout the duration of study until study close-out 7. Follow other SICR SOPs as pertaining to regulatory affairsExperience/Training:
Familiarity with clinical research protocols including human subjects' applications and informed consent documents. Must be able to maintain confidentiality. Demonstrated organizational skills including ability to develop accurate filing systems. Experience with computer systems and software (including databases, spreadsheets, and word processing). Ability to use software to develop organized information sources and to provide a variety of reports. Ability to Multi-task, work under deadlines, and very detail oriented Experience with Microsoft Office products such as: Word, Adobe and Excel.Educational Qualifications:
Minimum, Bachelor's Degree Specifications:
- Minimum 1 year of experience in/with clinical research required.
- Read, Write and Speak English Fluently
- Ability to respond appropriately to Sponsor/CRO representative
- Interaction with a wide variety of people
- Fast-Paced Environment
- Ability to project a professional, friendly, helpful demeanor Who We Are?