Clinical Research Coordinator

CRC monitors and coordinates multiple research projects in order to assess the need for and to implement strategies to ensure the conduct of quality research, the achievement of expected timelines and deliverables, and the efficient use of resources. CRC is responsible for assisting PIs with study protocol development, ICFs, and required study documents in preparation for IRB submission. Assists with recruitment activities, consents patients, ensures eligibility prior to enrollment, and randomizes patients to study. Abstracts data, completes case report forms and maintains research record and data integrity. Schedules and meets with study monitor for site visits, maintains data in an audit ready state, and ensures study meets the requirements of executed contract and budget. CRC ensures compliance to the research protocol, appropriate SOPs, policies and federal regulations while having a sound understanding of ICH/GCP guidelines and IATA requirements. Must have Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately. CRC may have other duties as assigned to facilitate incoming project, department, and institutional needs. Ability to work in an interprofessional setting, excellent written and verbal communication skills; ability to work with a diverse group of people to include physicians, patients and families. CRC will serve as a liaison and work closely with the investigators, department members, study sponsors, IRB and the institution, to support administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies.