Clinical Research Coordinator ll or III or IV Asthma Research

Cincinnati Children's Hospital Medical Center • Cincinnati, OH

359d

About The Position

At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's.

Requirements

• Bachelor's degree in a related field.
• 1+ years of directly related experience OR Master's degree in a related field.
• Knowledge of statistical process control principles.

Responsibilities

• Maintain awareness of status of all active studies and 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 or 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 with regulatory authorities.
• Document regulatory activities in appropriate systems.
• Determine additional requirements for research protocols and coordinate processes.
• Identify potential participants for research protocols and prepare accordingly.
• 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.
• Compose, document, organize, and maintain all correspondence.
• Serve as CCHMC liaison to internal departments and external organizations.
• Create CRFs in consultation with team members and ensure compliance with guidelines.
• Enter data into databases and oversee data entry and validation.
• Perform data cleaning procedures and quality checks.
• Assist in data analysis and maintain record keeping for clinical research studies.

Benefits

• Shift Differential, Weekend Differential, and Weekend Option Pay Programs.
• Medical coverage starting day 1 of employment.
• Competitive retirement plans.
• Tuition reimbursement for continuing education.
• Expansive employee discount programs through community partners.
• Referral bonus program for current staff.
• Support through Employee Resource Groups.
• Physical and mental health wellness programs.
• Relocation assistance available for some positions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Hospitals
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees