GENERAL SUMMARY:

• Responsible for keeping clinical research projects in compliance with the Code of Federal Regulations, Sponsor and System guidelines.
• Provide technical support to Principal Investigators.
• Analyze protocol specific requirements and implement quality assurance measures to ensure physician, patient and clinician compliance.
• Abstract medical information from various sources in the patient medical record.
• Report adverse events to medical monitor, FDA, and all other governing bodies.
• Manage all external audits and monitoring visits, and serve as liaison between institution and sponsor.
• Serve as departmental and system-wide resource.
• Manage the hiring, orientation, mentoring, work oversight, disciplinary actions, and performance review processes for the clinical research coordinators.

EDUCATION/EXPERIENCE REQUIRED:

• Bachelor's degree required.
• Four (4) years progressive clinical trial experience required.
• Two (2) years of supervisory experience strongly preferred.
• Organizational, analytical, and problem solving skills required.
• Demonstrated verbal and written skills at professional level required.
• CERTIFICATIONS/LICENSURES REQUIRED: SOCRA or ACRP and IATA certification required.

Preferred Skills

• A minimum of 2 yrs Supervisory experience
• Oncology Experience
• Registered Nurse- not required,but preferred

• Organization: Henry Ford Medical Group
• Department: Cancer Clinical & Trans Resear
• Shift: Day Job
• Union Code: Not Applicable