Nashville, Tennessee
Indianapolis, Indiana
Whittier, California
Cumberland, MD
Posted: 03-Aug-24
Location: Akron, Ohio
Salary: Open
Categories:
Internal Number: 22879
Full-time, 40 Hours/Week
Monday to Friday, 8a.m. - 4:30p.m.
Hybrid (Onsite 2-3 days/week)
Summary:
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Trial Supervisor and clinical Principle Investigator (PI) on multiple ongoing research studies. While the PI is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities in accordance with federal, state and local regulations, Institutional Review Board (IRB) approvals and Akron Children???s Hospital (ACH) policies and procedures. The CRC plays a critical role in the conduct of the study and works collaboratively with the entire ACH Research team, sponsors, and monitors to ensure productivity and timely completion of studies.
Responsibilities:
1.Recruit, screen, enroll and obtain consent/assent from research participants.
2.Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with IRB and regulatory agency regulations.
3.Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
4.Develops source documents, completes timely and accurate data collection, documentation, entry, and reporting in both sponsor and ACH databases.
5.Supports the regulatory document specialists in the maintenance of regulatory documents, study submissions and continuing reviews in accordance with Rebecca D. Considine Research Institute (RDCRI) SOP and policies and applicable regulations. Ensures appropriate credentialing and training of the entire ACH research team.
6.Communicates and collaborates specific study requirements to the research team, including internal and externa; parties, sponsors, monitors, PI, and study participants.
7.Ensures proper specimen handling, processing and shipping according to protocol
8.Utilizes the Clinical Trial Management System (CTMS) and adheres to protocol specific budgets
9. Other duties as required.
Other information:
Technical Expertise
1.Experience in clinical trial protocols is required.
2.Experience in interpreting medical charts and abstracting data is preferred.
3.Experience working with all levels within an organization is required.
4.Experience in healthcare is preferred.
5.Ability to work well independently as well as in team environment.
6.Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.
7.Occasional travel to attend sponsor study training meetings (required)
8.Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire.
Education and Experience1.Education: Bachelor???s degree in health-related field is required;
2.Certification: None.
3.Years of relevant experience: 2 years is preferred.
4.CPR ??? Certification required within 90 days of employment. Akron Children???s Hospital will facilitate training.