Clinical Research Project Manager - DDI

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 TitleClinical Research Project Manager - DDI                        LocationWeston                    FacilityKrupa Center Weston                     DepartmentResearch Administration-Research Innov and Educ                      Job CodeT26213                     ShiftDays                       Schedule8:30am-4:30pm                       Job Summary                         Job DetailsJoin the Cleveland Clinic Florida team at the Krupa Center in Weston, where you will work alongside highly skilled and compassionate caregivers and board-certified family practice physicians to provide patient-first healthcare. Cleveland Clinic is consistently recognized as one of the top hospitals in the nation, offering quality preventive care, management of chronic conditions and comprehensive services for the entire family. At Cleveland Clinic, you will receive strong support and recognition, collaborate with dedicated professionals and build a rewarding career with one of the world’s most respected healthcare organizations.  As a Clinical Research Project Manager for the DDI team, you will oversee the administrative functions of single- and multi-institutional research trials while managing the daily operations and organizational activities of Phase I–IV clinical studies. This role combines both patient-facing and administrative responsibilities, with approximately 60% of time spent directly interacting with patients and 40% focused on study coordination and management activities. You will coordinate IRB submissions, collect research data from participants, draft study protocols, and facilitate communication among investigators, patients, and international collaborators.The research program is dedicated to improving quality of life following cancer surgery, placing patients at the center of every project. Working closely with patient partners, you will help incorporate their perspectives into research design and execution, fostering a collaborative approach that enhances the patient’s experience and advances meaningful, patient-centered outcomes.A caregiver in this role works days from 8:30 a.m. – 4:30 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 fieldOR High School Diploma/GED and seven years of experienceOR Associate’s Degree and five years of experienceOR 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 levelsWithin 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 ClinicPreferred qualifications for the ideal future caregiver include:  Master’s degreeSociety of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) CertificationFive years of research experienceSupervisory experience