Clinical Research Coordinator II - Patient Data & Protocols

Creighton University; Omaha (NE); On-site; USD 55,000 - 75,000; Full time

Job summary

Creighton University is seeking a Clinical Research Coordinator to support clinical projects by gathering information, managing participant progress per protocol, and assisting with data analysis. The role requires discretion and accuracy in reviewing study data and procedures.

The position involves coordinating participant visits, data entry, and regulatory reporting. A related bachelor's degree and 4 years of clinical research experience are preferred, with knowledge of FDA regulations and

Qualifications

• Must have a Bachelor's degree in a related field.
• Minimum 4 years clinical experience, preferably in a research setting.
• Knowledge of FDA regulatory requirements.
• Knowledge of the principles of research design.
• Ability to maintain confidentiality.
• Ability to operate personal computer and various software packages.

Responsibilities

• Meets with study participants. Follows study protocol performing duties/testing/data collection.
• Records data into patient research case report forms (CRFs) including results and abnormal findings.
• Schedules appointments for procedures inside and outside the department.
• Maintains study drug and supply inventory and disbursement.
• Reports regulatory and Institutional Review Board issues appropriately (e.g., adverse events).

Skills

FDA regulatory requirements

Principles of research design

Confidentiality

Computer skills

Education

Bachelor's degree in related field

Job description

Creighton University is seeking a Clinical Research Coordinator to support clinical projects by gathering information, managing participant progress per protocol, and assisting with data analysis. The role requires discretion and accuracy in reviewing study data and procedures.

The position involves coordinating participant visits, data entry, and regulatory reporting. A related bachelor's degree and 4 years of clinical research experience are preferred, with knowledge of FDA regulations and