Clinical Research Project Manager - Respiratory

                    

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 - Respiratory

                        

Location

Cleveland

                    

Facility

Cleveland Clinic Main Campus

                     

Department

Research Administration-Research Innov and Educ

                      

Job Code

T26213

                     

Shift

Days

                       

Schedule

8:00am-5:00pm

                       

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.  

As a Clinical Research Project Manager, you will oversee the administrative functions of the Integrated Hospital Care Institute research portfolio, specifically Pulmonary Medicine, and support a growing team of coordinators. In this role, you will train and support coordinators while managing a broad range of research projects as the Respiratory Institute continues to expand. You will coordinate and manage daily operations and organizational activities related to Phase I to IV clinical trials, facilitate key communications for academic coordination, and provide clinical insight to support the design and conduct of clinical studies.

A caregiver in this role works days from 8:00 a.m. – 5:00 p.m.

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. 

• Provide clinical perspective to the design and conduct of clinical trials. 

• 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 sponsors, 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. 

• 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. 

• Lead initiatives to improve quality and make recommendations to discontinue sites if necessary. 

• Assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention. 

• Complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.

• Perform other duties as assigned.

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 rese