CRC- Eau Claire, WI

Job Summary:

The Clinical Research Coordinator (CRC) is responsible for overseeing the execution of clinical study protocols in strict compliance with Good Clinical Practice (GCP) and Food and Drug Administration (FDA) regulations. The CRC will be primarily focused on conducting multiple clinical trials, collaborating closely with the Principal Investigator, Sub-Investigators, and support personnel.

Key Responsibilities:

1. Accurately and comprehensively interprets study protocols to ensure consistent adherence to relevant standards and associated requirements.
2. Educates both patients and healthcare professionals on the study protocol to ensure a thorough and accurate understanding of the information.
3. Evaluates medical records against inclusion/exclusion criteria to identify potential study subjects.
4. Effectively communicates information and addresses questions in accordance with professional practice standards and compliance requirements, particularly regarding the process of obtaining informed consent.
5. Maintains and prepares laboratory kits for subject visits.
6. Coordinates subject visits in collaboration with the Investigator Team.
7. Manages clinical source records.
8. Organizes Investigator Site Files.
9. Ensures the accuracy of call notes and documentation.
10. Adheres to all regulatory requirements, guidelines, and local regulations.
11. Prepares Institutional Review Board (IRB) submissions, including the development of Informed Consent Forms (ICF) and any necessary supporting documentation.
12. Compiles Regulatory documents as per sponsor requirements, including FDA Form 1572 and Financial Disclosure forms.
13. Coordinates and maintains various logs, such as the Delegation of Authority, Deviation Logs, Enrollment, and Study Status Logs.
14. Organizes and conducts Site Training.
15. Transcribes source data to Electronic Data Capture (EDC) platforms.
16. Hosts Sponsor and Monitor Visits.
17. Demonstrates integrity, teamwork, respect, and accountability in all aspects of the role.
18. Performs job duties and assigned tasks in a safe, efficient, and effective manner, in full compliance with company policies, procedures, protocols, and practices.
19. Undertakes other duties as assigned, as required to meet the business needs.

Additional Details:

Location: Eau Claire, WI (54701)

Pay: $45K-$75K Annual Salary (Dependent on years of experience)

Hours: Monday - Friday; Normal Business Hours (Onsite 5 Days a Week)

Employment: Direct Hire

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