Clinical Research Specialist II - Protocols & Mentorship

University Hospitals; Cleveland (OH); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

University Hospitals in Cleveland, OH is seeking a Clinical Research Coordinator to coordinate the implementation of complex trials with the Principal Investigator. The role emphasizes regulatory submissions, file maintenance, and adherence to GCP.

You will screen participants, obtain informed consent, manage study documents, and assist with manuscript preparation while mentoring junior staff and ensuring PHI compliance.

Qualifikationen

• Experience coordinating complex clinical trials with PI oversight.
• Strong understanding of regulatory requirements and SOPs.
• GCP knowledge and good documentation practices.
• Attention to accurate data capture and record keeping.

Aufgaben

• Submit related documents to regulatory review committees and maintain regulatory files.
• Screen participants for eligibility, obtain informed consent, educate participants, and complete CRFs.
• Maintain in-depth knowledge of protocol requirements and GCP guidelines.
• Document and assimilate accurate participant and study records per sponsor and SOPs.
• Assist with SOP, grant and protocol development; contribute to manuscripts and presentations.
• Establish and maintain communications with Investigator, Sponsor and internal stakeholders.
• Mentor junior clinical research staff in the clinical research process.
• Performs other related duties as assigned or required.

Kenntnisse

Trial coordination

Regulatory compliance

GCP knowledge

Participant recruitment

Documentation accuracy

Jobbeschreibung

University Hospitals in Cleveland, OH is seeking a Clinical Research Coordinator to coordinate the implementation of complex trials with the Principal Investigator. The role emphasizes regulatory submissions, file maintenance, and adherence to GCP.

You will screen participants, obtain informed consent, manage study documents, and assist with manuscript preparation while mentoring junior staff and ensuring PHI compliance.