- Study Conduct/ Clinical Research Practice
- Regulatory Compliance and Documentation
- Recruitment/Enrollment/Retention
- Communication
- Data Management
- Bachelor's degree and 2 years of work experience in a related job discipline or Master's degree
Clinical Research Coord III - Cincinnati, United States - Cincinnati Children's Hospital Medical Center
Description
Expected Starting Salary Range:
SUBFUNCTION DEFINITION:
The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.
These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.REPRESENTATIVE RESPONSIBILITIES
Assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor.
Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set.
Ensure specimens are properly logged, handled and stored. Follow direction of clinical research coordinator or others involved in the clinical research project work. Assist other staff members and coordinators to implement studies. Maintain inventory of supplies and equipment. Operate standard laboratory and research study equipment, if applicable. Troubleshoot and correct erroneous results or problems with equipment.Demonstrate an awareness of federal regulations; state and local law; GCP/ICH and CCHMC policies to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
Recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisor in a timely manner.Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with the institution and division SOPs.
Seek out research educational opportunities.Participate in meetings, discussions and activities designed to improve organizational performance through recommending areas or approaches for improving study conduct.
EDUCATION/EXPERIENCE
Required:
Preferred:
Unique Skills:
Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).