Clinical Research Quality Assurance Specialist - Cancer & Blood Diseases Instiute

Cincinnati Children's Hospital Medical Center • Cincinnati, OH

135d • $55,785 - $69,076

About The Position

The Clinical Research Quality Assurance Specialist at the Cancer & Blood Diseases Institute in Cincinnati, Ohio, is responsible for ensuring the quality and compliance of clinical trials. This role involves reviewing and analyzing clinical trial data and documentation, developing monitoring plans, and providing guidance to clinical faculty and staff. The specialist will also develop comprehensive data safety monitoring plans, assist in audits and inspections, and provide training on clinical trial protocols and regulations.

Requirements

• Bachelor's degree in a related field.
• 2+ years of work experience in a related job discipline.
• SoCRA or ACRP certification within 18 months of external hire.

Responsibilities

• Review and analyze clinical trial data and related documentation.
• Provide guidance to clinical faculty and staff in clinical research documentation.
• Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs.
• Develop and communicate outcome measures.
• Prepare and execute monitoring plans for clinical trial activities.
• Conduct site visits to ensure protocol and regulatory compliance.
• Verify essential documents are accurate, complete, and maintained.
• Assist in the development and implementation of action plans for external monitoring/audit follow-up.
• Assist in preparation and conduct of audits/surveys/inspections by regulatory agencies.
• Develop improvement plans using quality improvement methods.
• Provide input into the development of new protocols and plans for implementing new trials.
• Participate in the development of investigator-led protocols.
• Develop and maintain SOPs for clinical trials.
• Act as a primary resource for clinical trials staff.
• Assist in developing and providing clinical trial training and consultation.

Benefits

• Medical coverage starting day one of employment.
• Competitive retirement plans.
• Tuition reimbursement for continuing education.
• Expansive employee discount programs.
• Shift Differential, Weekend Differential, and Weekend Option Pay Programs.
• Support through Employee Resource Groups.
• Physical and mental health wellness programs.
• Relocation assistance available for qualified positions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree