- Study Conduct/ Clinical Research Practice
- Regulatory Compliance and Documentation
- Recruitment/Enrollment/Retention
- Communication
- Data Management
- Bachelor's degree in a related field
- Knowledge of statistical process control principles
- 1 year of directly related experience OR Master's degree in a related field
clinical research coord iii - Cincinnati, OH , USA, 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
Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set.
Ensure specimens are properly logged, handled and stored. Maintain all records and files required by regulatory agencies and sponsors. Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies. Train new staff in preparation and conduct of clinical trials.
Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties.
Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations.
Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain up-to-date & accurate written & electronic records & files to support clinical research activities. Continuously update knowledge of regulatory requirements.May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues.
Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly.
Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, government agencies, academic centers, and other organizations.
Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers and other institutions. Develop a rapport with study participants.
Create CRFs in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation to ensure accuracy, completeness of data collection process.
Perform data cleaning procedures and quality checks to ensure accuracy of data. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Review reports, tables, and listings. Assist in data analysis and maintain record keeping and data storage for clinical research studies. Maintain master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects.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).