Research Coordinator II - Blood and Marrow Transplant

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 Research Coordinator II - Blood and Marrow Transplant Location Cleveland Facility Remote Location Department Taussig Administration-Cancer Institute Job Code T99498 Shift Days Schedule 8:00am-4:00pm Job Summary Coordinates the compliant implementation and conduct of human subject research projects typically of medium workload and medium complexity. Job Details Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. The Cancer Center Research department is part of Cleveland Clinic’s Taussig Cancer Institute, which is known for continuous clinical trials and cancer research to ensure our patients have access to the newest advances in cancer treatment. As Research Coordinator II, you will coordinate the compliant implementation and conduct of human subject research projects, typically of low workload and low complexity. This role will informally lead a team made up of various members including Physicians, Nurses, Research Coordinators, lab personnel, Financial Analysts and Quality Assurance Coordinators. The ideal caregiver is someone who: • Demonstrates a strong work ethic. • Thrives in a team environment. • Has strong communication and problem-solving skills. • Is self-directed and organized. This role provides you with the opportunity to work on cutting edge research, work with some of the most accomplished physician scientists in the country and work with the most innovative pharmaceutical companies in the world. You will work in a dynamic and technologically advanced environment that allows you to learn, grow and remain professionally challenged as you shape the career of your dreams and find where you belong, here at Cleveland Clinic. At Cleveland Clinic, we know what matters most. That's why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you. Here, you'll find that we offer: resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being and your future. When you join Cleveland Clinic, you'll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare. Responsibilities: • Abstracts cellular therapy/BMT data and manages internal BMT database by data entry and data reporting. • Completes Center for International Blood & Marrow Transplant Research (CIBMTR) data forms supporting research in cellular therapies to improve patient outcomes. • Assists with preparation for audits and response to audits. • Monitors research data to maintain quality. • May assist with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team. • May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines as applicable. • May communicate with sponsors, monitors, research personnel to ensure all aspects of study compliance. • May collaborate with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits. • May collaborate with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment. • Monitors and reports project status. • Completes regulatory documents, data capture and monitoring plans. • Assists with completion of protocol related activities. • As delegated, may be required to attain and maintain clinical competencies for unlicensed caregivers such as phlebotomy, vital signs, ECG, POC testing and other testing as required. • Monitors research data to maintain quality. • Understands basic concepts of study design. • Demonstrates comprehension of assigned research protocols. • May develop and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols. • Assists with preparation for audits and response to audits. • May assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures. • Maintains study personnel certification records (License, CV, CITI). • Maintains professional relationships, including frequent and open effective communication with internal and external customers. • Documents the education and training of research personnel as needed. • May participate in the conduct and documentation of the informed consent process. • May contribute to research project budget development. • Performs other duties as assigned. Education: • High School Diploma or GED. Associate's or Bachelor's degree in health care or science related field preferred. Degree may offset experience requirement. • Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing spreadsheets, database and presentation software, and the ability to undertake internet searches. • Solid written and verbal communication skills. • Must be self-directed with demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team. • Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic. Languages: • Language required • Language preferred Certifications: • None required. Complexity of Work: • Requires excellent organizational, written, and verbal communication skills. • Must be able to take direction and appropriate action in a stressful environment. Work Experience: • Minimum two years clinical research or healthcare experience required. • Associate's or Bachelor's degree in healthcare or science field may offset experience requirement. • Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing, spreadsheets, database and presentation software, and the ability to undertake internet searches. Solid written and verbal communication skills. Physical Requirements: • A high degree of dexterity to produce materials on a computer. • Requires normal or corrected vision and hearing to normal range. • Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds. • May have some exposure to communicable diseases or body fluids. • May require working irregular hours. 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 Apply tot his job