Medix Staffing Solutions
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Clinical Research Coordinator
at Medix Staffing Solutions
The candidate will be coordinating clinical research protocols from study start up to close out. This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Counsil of Harmonization, and Good Clinical Practices.
Essential Duties and Responsibilities:
- Recruiting and consenting patients
- Responsible for regulatory submissions. Needs working knowledge of essential documents and IRB requirements.
- Collects, verifies, organizes and records clinical information and data in electronic data capture systems (EDC). Abstracts data from necessary sources to complete the EDC and resolve queries. Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding
- Plans and coordinates strategies for increasing patient enrollment.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board).
- Maintains research practices using Good Clinical Practice (GCP) guidelines and maintain strict patient confidentiality according to HIPAA regulations and applicable law.
- Creating and developing presentations.
- Acts as liaison with sponsor/CRO
- Developing and negotiating budgets
- Maintain study specific calendars and notifies investigators of study visits, meeting, and research related activities