Clinical Research Coordinator II

Creighton University • Omaha, NE

1d

About The Position

Under general supervision, independently gathers research information for clinical projects. Manages clinical course of research participants according to research protocol. Selects and observes subjects and assists with data analysis. Utilizes discretion, creativity and latitude for decision making.
Essential Functions:
Meets with study participants. Follows study protocol performing duties/testing/data collection. Conducts study required tests and procedures. (Test may include: bone density scans, EKG's, balance testing, mental and physical assessments, blood draws, vitals, diary instruction and review, etc.)
Records data into patient research case report forms (CRF's) to include recording test results and reacting appropriately to abnormal results. Maintains accurate CRF's and source documents
Schedules appointments for various procedures inside and outside the department. Obtains medical records for any research hospitalizations and various other duties assigned.
Maintains study drug and supply inventory as well as study drug disbursement
Reports regulatory and Institutional Review Board issues appropriately (i.e. report adverse events and other regulatory data)

Requirements

• Bachelor's Degree in related field of Science preferred
• 4-6 years clinical experience preferably in a research setting
• Excellent verbal and written communication skills required
• Organizational and analytical skills required
• Knowledge of FDA regulatory requirements is required
• Knowledge of the principles of research design
• Interpersonal/human relations skills
• Attentiveness to detail
• Ability to maintain confidentiality
• Ability to operate personal computer and various software packages
• Basic Life Support (BLS) within 90 days of hire.

Responsibilities

• Meets with study participants.
• Follows study protocol performing duties/testing/data collection.
• Conducts study required tests and procedures. (Test may include: bone density scans, EKG's, balance testing, mental and physical assessments, blood draws, vitals, diary instruction and review, etc.)
• Records data into patient research case report forms (CRF's) to include recording test results and reacting appropriately to abnormal results.
• Maintains accurate CRF's and source documents
• Schedules appointments for various procedures inside and outside the department.
• Obtains medical records for any research hospitalizations and various other duties assigned.
• Maintains study drug and supply inventory as well as study drug disbursement
• Reports regulatory and Institutional Review Board issues appropriately (i.e. report adverse events and other regulatory data)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees