Clinical Trial Coordinator BWH TIMI

Brigham and Women's Hospital
United States, Massachusetts, Boston
350 Longwood Avenue (Show on map)
Jan 21, 2025
Responsible for ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to 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? -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 Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials 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, the 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.