Clinical Research Project Manager - Pediatrics

                    

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.

                        

We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One.

                                    

Job Title

Clinical Research Project Manager - Pediatrics

                        

Location

Cleveland

                    

Facility

Cleveland Clinic Main Campus

                     

Department

Peds Division Office-Children's Institute

                      

Job Code

T26213

                     

Shift

Days

                       

Schedule

8:00am-5:00pm

                       

Job Summary

                         

Job Details

**Applicants must reside near Cleveland, OH

Join Cleveland Clinic Children's where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Cleveland Clinic Children's team of more than 300 caregivers are dedicated to the medical, surgical, and rehabilitative care of infants, children and adolescents. Here, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and make meaningful differences in the lives of others every day. 

As a Clinical Research Project Manager, you will handle various research-related projects within the Pediatrics department. In this role, you will focus on performing the essential behind-the-scenes work required to support innovative treatments. You will contribute clinical insight to the design and conduct of these trials and oversee administrative functions for single and multi-institutional research trials. You will also manage the daily operations of Phase I–IV clinical studies and facilitate key communications to support academic trial coordination. 

This is a hybrid position after the new hire period (3-6 months). A caregiver in this position works 8:00am to 5:00pm. Some flexibility with start and end times will be needed.

A caregiver who excels in this role will:  

• Oversee the administrative functions of single and/or multi-institutional research trials.  
• Coordinate/manage daily organization and operational issues/activities related to Phase I-IV clinical research trials.   
• Facilitate key trial communications for academic coordination. 
• Manage and coordinate a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis. 
• Interact with the Finance and Legal departments to facilitate clinical trial budget, site budget and contract execution. 
• Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA. 
• Collect and review regulatory documents from sites. 
• Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues. 
• Organize, coordinate, attend and participate in Investigator Meetings and training programs. 
• Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.). 
• Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites. 
• Assess investigator and site performance. 
• Improve quality and make recommendations to discontinue site if necessary. 
• May assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention. 

Minimum qualifications for the ideal future caregiver include:  

• Bachelor’s Degree in Nursing, Science, Healthcare or Computer Science with an emphasis on programming and three years of clinical research experience as a Study Coordinator