The Cardiac Imaging Core Lab (CICL) is located within the Brigham and Women's Hospital, a Harvard-affiliated hospital that is situated directly adjacent to Harvard Medical School. The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. The CICL is an academic-oriented research organization that works with academic, government, and industry partners and collaborators nationally and internationally. Working under the direction of CICL Directors and the Operations Director, the Research Assistant I will be an integral member of the CICL and will be responsible for 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 Research Assistant I will interact with research collaborators within other Harvard departments and at other institutions across the U.S. and other countries around the world.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
Day-to-Day Study Operations:
- 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-to-day 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.
- 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 biological sciences or health administration.
- Candidate must be highly proficient in Word and Excel, knowledgeable of Access and PowerPoint and be generally comfortable working with computers.
- Ideal candidate 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.
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
- 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; ie. other Center project staff, technical staff, Directors, enrolling sites, Sponsors and other affiliate groups
- very dependable and able to demonstrate a respect for the importance of how work practices affect data quality
- able to communicate concisely and effectively, without undue delays, both verbally and in writing
- a clinical research professional, or aspires to become one, with an interest in cardiovascular medicine, human subject research and clinical trial project management.
Due to Covid 19 this position will support working remotely, but the expectation is that it will transition to a professional academic/office environment upon request of the CICL Director, which may occur at any time. This position is M-F during core business hours.EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.