Clinical Research Project Manager NE - HVTI Research & Registries

                    

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 NE - HVTI Research & Registries

                        

Location

Cleveland

                    

Facility

Cleveland Clinic Main Campus

                     

Department

HVTI Research and Registries-Heart Vascular & Thoracic Institute

                      

Job Code

D99704

                     

Shift

Days

                       

Schedule

8:00am-5:30am

                       

Job Summary

                         

Job Details

Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. 

This role manages the full administrative and operational lifecycle of Phase I-IV clinical research trials. Acting as a central coordinator, the position ensures seamless communication and collaboration among investigators, sponsors, regulatory bodies, and internal teams. A critical part of the role is guiding physicians in protocol development and ensuring regulatory compliance, especially given that many clinicians lack in-depth regulatory knowledge. You interact with physicians and investigators, clinical trial sponsors, clinical research team members, regulatory bodies (IRB and FDA), other internal departments and external research sites. 
 

The position requires managing several concurrent studies (typically 4–5), which may vary in length from a few months to over a decade (especially for device trials).  
 

Responsibilities also include site selection, performance assessment, and recommending continuation or termination of site participation based on quality. The project manager plays a vital role in protocol review and site monitoring coordination. Experience in cardiovascular research (particularly within the HVTI network) is valuable, and international collaboration is part of the role, including work with physicians in Abu Dhabi. 

A caregiver in this position works part-time, 4 days per week from 8:00am—5:00pm. (M-F) Day off during the week can be flexible.

A caregiver who excels in this role will:  

• 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. 

• Maintain professional relationships with Sponsor including frequent, open communication and associated documentation. 

• 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.