Clinical Research Coordinator II/III - Asthma Research

Cincinnati Children's Hospital Medical Center • Cincinnati, OH

135d

About The Position

The Clinical Research Coordinator II/III position at Cincinnati Children's focuses on managing clinical research studies related to asthma. The role involves maintaining awareness of all active studies, ensuring compliance with study protocols, and collaborating with investigators and study teams. Responsibilities include regulatory compliance, participant recruitment and retention, data management, and communication with various stakeholders. The position requires a proactive approach to problem-solving and innovation in overcoming recruitment barriers.

Requirements

• High school diploma or equivalent, and 2 years of work experience in a related job discipline for CRC II.
• Bachelor's degree in a related field preferred for CRC II.
• Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field for CRC III.

Responsibilities

• Maintain awareness of status of all active studies.
• Arrange for facilities and supplies.
• Ensure participant and study compliance, including collection of study specimens and study visits.
• Work with study team to define specimen collection, processing, and storage procedures.
• Train others to collect and label samples and deliver/process samples according to protocols.
• Ensure specimens are properly logged, handled, and stored.
• Maintain records and files required by regulatory agencies and sponsors.
• Serve as a resource for other clinical research professionals.
• Collaborate with investigators and coworkers to ensure proper progress and completion of clinical studies.
• Train new staff in preparation and conduct of clinical trials.
• Prepare, submit, and maintain all regulatory submissions accurately and timely.
• Self-audit records to ensure audit-readiness.
• Prepare and participate in monitor visits, audits, and quality reviews.
• Oversee review and approval of human research protocols.
• Document regulatory activities in appropriate systems.
• Determine best methods to identify potential participants for research protocols.
• Create and maintain a tracking system for participants considered for enrollment.
• Conduct pre-consent screening to determine eligibility.
• Execute the informed consent process according to GCP and CCHMC procedures.
• Communicate with participants' clinical team regarding study participation.
• Document participants approached, screened, and enrolled in the study.
• Communicate challenges with recruitment and retention to study leadership.
• Engage study staff to assist in identifying and enrolling participants.
• Create CRFs in consultation with team members.
• Complete CRFs and source documentation in compliance with guidelines.
• Enter data into databases and oversee data entry and validation.
• Perform data cleaning procedures and quality checks.
• Support the data-management process for clinical research projects.

Benefits

• Medical coverage starting day one of employment.
• Competitive retirement plans.
• Tuition reimbursement for continuing education.
• Expansive employee discount programs through community partners.
• Shift Differential, Weekend Differential, and Weekend Option Pay Programs for qualified positions.
• 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