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Clinical Trial Coordinator BWH Cardiovascular
4 months ago
Day-to-Day Study Operations
* 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.
Data Management
* 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.
General
* 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.
SKILLS/ABILITIES/COMPETENCIES REQUIRED
Given 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:
* 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
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.
