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 - Endocrinology

                        

Location

Cleveland

                    

Facility

Cleveland Clinic Main Campus

                     

Department

Endocrinology-Medical Specialty Institute

                      

Job Code

T26213

                     

Shift

Days

                       

Schedule

8:00am-4:30pm

                       

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 research projects within the Endocrine and Allergy departments, focusing on the “behind-the-scenes” work that supports innovative treatments. In this role, you will collaborate closely with researchers and clinical caregivers, contributing to budgets and contracts, monitoring patient visits and supporting essential research activities. In collaboration with clinician-scientists, you will contribute to the realization of their research initiatives and support the ongoing growth and success of the Endocrine and Metabolism and Allergy and Immunology Research Departments. This position offers continued learning and growth, all while allowing you to not only make a difference in Cleveland but potentially the world.  

This position is an excellent opportunity for individuals interested in advancing into a leadership role. It provides experience in team and workload management, training and coaching staff, research financial operations, and the regulatory requirements for conducting clinical research at Cleveland Clinic.

A caregiver in this role works a hybrid schedule from 8:00 a.m. – 4:30 p.m. with two to three days at home and two to three days on Main Campus each week.

This position will be based at Main Campus and occasional travel to other CCF locations in Ohio may be required (Twinsburg Family Health Center, Strongsville etc.)

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) within 90 days or hire.  

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, Project Manager, Contract Research Associate or equivalent in a related field

• OR High School Diploma/GED and seven years of experience

• OR Associate’s Degree and five years of experience

• OR Master’s Degree and two years of experience 

• Substantial scientific and medical knowledge across relevant therapeutic areas  

• Demonstrated ability to work with multiple software technologies 

• Knowledge of FDA regulations, GCPs and internal SOPs 

• Knowledge of the Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials 

• Background/ability or working with clinical studies and clinical research team members at all levels.

• Within 90 days of hire, must successfully complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic

Preferred qualifications for the ideal future caregiver include:  

• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification 

• Supervisory experience 

• Familiar with clinical research practices and policies at the Cleveland Clinic

• Knowledge of all types of clinical research (industry sponsored, IIT etc)

• Experience working with the CCF IRB

• Experience working directly with patients and Principal Investigators

Physical Requirements:

• Requires full range of motion, manual and finger dexterity and eye-hand coordination.

• Requires standing and walking for extensive periods of time.

• Requires normal or corrected hearing and vision to normal range.

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.

                       

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility. 

Please review the Equal Employment Opportunity poster. 

                  

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities