Clinical Trial Coordinator

The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women's Hospital, a Harvard‑affiliated hospital. The CICL provides echocardiography (echo) core laboratory services for large–scale global clinical trials, responsible for site training and interface as well as quantitative echo analysis of images received. The CICL works primarily with sponsors, CROs, and clinical trial sites which send echos directly to the CICL. Approximately 40 staff support 40+ ongoing trials, with a typical volume of 1,000-1,500 echos received each month. Under the direction of the CICL Operational Director and study‑specific Project Manager, the Clinical Trial Coordinator (CTC) is an integral member of the CICL, assisting with day‑to‑day project activities such as image receipt, progress reporting, data transfers, communications with study sponsors, study sites, and study team members. The CTC interacts with research collaborators within other Harvard departments, various Sponsors, CROs, and enrolling sites worldwide. Summary Responsible for ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and sponsor standards. Working independently and under general supervision, will support one or more clinical trials and will be responsible for assigned administrative day‑to‑day project activities. Does this position require Patient Care? No Essential Functions Identify and initiate communications with sites to obtain all relevant documents for project/trial. Collect and review the site's essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval. Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues. Update and maintain internal databases, tracking systems, project plans, and study files. Prepare presentation materials for internal and external meetings. Draft meeting agendas and minutes. Work with Project Manager to support trial processes and distribution of information and reports to monitors. Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial. Comply with applicable SOPs. Education Bachelor's Degree in a related field of study required. Can this role accept experience in lieu of a degree? No Experience Research related experience 1-2 years required, or familiarity with EDC and CTMS systems 2-3 years preferred. Knowledge, Skills and Abilities Excellent organizational skills. Solid written and verbal communication skills. Strong sense of accountability, ability to work autonomously. Ability to communicate effectively in a matrix environment. Ability to manage multiple tasks concurrently and to prioritize work appropriately. The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. #J-18808-Ljbffr