Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/Manages daily organization and operational issues/activities related to Phase I-IV clinical research trials. Facilitates key trial communications for academic coordination, provides clinical perspective to the design and conduct of clinical trials. Join Cleveland Clinic Research, where you will work alongside passionate caregivers and make a lasting, meaningful impact on patient care. Here, you will receive endless support and appreciation while building a rewarding career with one of the most respected healthcare organizations in the world. Groundbreaking discoveries happen every day at Cleveland Clinic. As a Clinical Research Project Manager, you will interact with various research teams and play a crucial role in managing the clinical research that allows Cleveland Clinic to continue to innovate and drive better outcomes for patients. Clinical research is the only way that medicine comes on the market, pushing the edge of moving medicine forward. Come join a culture devoted to pushing the needle forward in healthcare. In Pediatric Hematology and Oncology you will support research and clinical trials for our youngest cancer patients. Learn more here A caregiver in this role works days from 8:30am-5:00pm. Start/end times may vary. 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 Grant submission and post-award 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.

Pay Range Minimum Annual Salary:

$63,250.00

Maximum Annual Salary:

$96,467.50 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).