- One of the day to day responsibilities for this role is to provide daily administrative support to the Director.
- Provide clear and consistent organization of each assigned trial's status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks and overseeing project timelines.
- Ensure smooth and efficient internal day-to-day operations for each assigned study. This will include serving as the primary liaison with physician staff to answer questions, track progress and field queries.
- Serve as the primary liaison to the Study sponsors and/or Data Coordinating Centers for day-today operations; this may include issues related to specific events or address project-wide issues, key person involved in other key communique such as site visits, study meetings and audits.
- Maintain appropriate document control standards per SOPs.
- Creation of new, and management of existing CICL databases.
- Responsible for generating both study-specific progress reports and data as well as generating center-wide cumulative data and progress reports.
- Work with Study Sponsors and/or Data Coordinating Centers along with the CICL Clinical Data Coordinator to ensure proper data management, including data transfers of final data to study Sponsors.
- Facilitate the implementation and ongoing process improvement of established CICL Policies and Procedures; responsible for monitoring the effectiveness and adherence to policies, generation of new policies, prn.
- Provides other support as per the CICL Directors as it relates to the overall research scope of the CICL.
- BA/BS degree in health sciences or physiology or related field.
- Intermediate experience in Microsoft office including Excel.
- Ideal candidate will possess basic understanding of cardiac anatomy and physiology and some general medical knowledge.
- Has an interest in clinical research and/or trial project management and have a basic understanding of FDA regulations, ICH and GCP guidelines concerning human subject research.
- Highly organized and systematic in work processes.
- Able to perform a variety of general technical, research administrative and professional duties to support research activities of technical team.
- Self-motivated and proactive; able to identify, track, and drive issue resolution with little or no supervision or prompting
- Able to function at a high level in a dynamic and busy environment
- Able to take direction from, as well as influence and establish strong working relationships with a wide variety of individuals at all levels throughout CICL
- Very dependable and able to demonstrate a respect for the importance of how work practices affect data quality.
- Able to learn how research and sponsor-related contractual obligations work.
- Able to communicate concisely and effectively, without undue delays, both verbally and in writing
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Brigham & Women's Hospital(BWH) Boston, United StatesGENERAL SUMMARY: · 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 core laboratory services for primarily large-scale global clinical trial ...
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Brigham & Women's Hospital(BWH) Boston, United StatesDay-to-Day Study Operation · One of the day to day responsibilities for this role is to provide daily administrative support to the Director. · Provide clear and consistent organization of each assigned trial's status with strong attention to detail; this includes hands-on task ...
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Clinical Trial Coordinator BWH Cardiovascular - Boston, United States - Brigham and Women's Hospital
Description
Day-to-Day Study OperationsGiven this is a project environment and multiple projects will be assigned, and given that each project will have unique project demands, staff, deliverables and timeline, the ideal candidate is:
SUPERVISORY RESPONSIBILITIES
None.
WORKING CONDITIONS
This candidate works under close supervision of the technical director and within established CICL policies and procedures. The CICL supports a hybrid work model with required in-office time. This position is M-F during core business hours. There is no patient interaction in this position.
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