Genetics Clinical Research Specialist II – Trials Lead

University Hospitals; Cleveland (OH); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

University Hospitals in Cleveland, OH seeks a Clinical Research Specialist II, Genetics to coordinate complex trials under PI supervision. You will manage regulatory filings, consent processes, and CRFs while upholding GCP standards and sponsor guidelines. You’ll support SOPs, grants, and manuscript prep and mentor junior staff.

The role requires a Bachelor's degree and 2+ years of clinical research experience, with strong communication and documentation skills. Travel is possible as needed.

Qualifikationen

• Bachelor's degree is required in a related field.
• 2+ years of clinical research experience required.
• Experience working in a team environment is required.
• Knowledge of GCP and FDA guidelines is required.
• Ability to train and mentor junior staff.
• Strong attention to detail and documentation skills.

Aufgaben

• Coordinate regulatory submissions 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 participant and study records per SOPs and sponsor guidelines.
• Assist with SOPs, grants and protocol development; prepare manuscripts and presentations.
• Establish and maintain communications with investigators, sponsors and internal teams.
• Mentor junior staff in the clinical research process.
• Perform other related duties as assigned or required.

Kenntnisse

GCP guidelines

FDA guidelines

EDC software

Medical terminology

Mentoring

Communication

Time management

Detail oriented

Independent work

Customer service

MS Office

Ausbildung

Bachelor's Degree

Tools

EDC software

Microsoft Excel

Word

PowerPoint

Outlook

Jobbeschreibung

University Hospitals in Cleveland, OH seeks a Clinical Research Specialist II, Genetics to coordinate complex trials under PI supervision. You will manage regulatory filings, consent processes, and CRFs while upholding GCP standards and sponsor guidelines. You’ll support SOPs, grants, and manuscript prep and mentor junior staff.

The role requires a Bachelor's degree and 2+ years of clinical research experience, with strong communication and documentation skills. Travel is possible as needed.