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 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

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. If applying for a Florida position, please see the following website for more information on the background screening requirements required by the

Agency of Health Care Administration:

https://info.flclearinghouse.com/ Please review the Equal Employment Opportunity poster. Cleveland Clinic is pleased to be an equal employment opportunity employer. We know that fully supporting our caregivers is what creates the best outcomes for our patients. Our outstanding, comprehensive offerings are an investment in your health, well-being and future. What began in Cleveland in 1921 has grown to include locations throughout, the U.S. and even other countries. For you, that means more opportunities to learn, grow and serve patients — while finding caring, thriving communities both at work and at home. Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Headquartered in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 70,800 employees worldwide represent 140 medical specialties and subspecialties. Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 19 hospitals, more than 220 outpatient facilities, and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England.