Clinical Trial Coordinator BWH Cardiovascular

Clinical Trial Coordinator BWH Cardiovascular-(3292455)

Description

GENERAL 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 trials responsible for site training and interface as well as echo analysis of images received.

The CICL works primarily with sponsors, CROs, and clinical trial sites which send echos directly to the CICL.There are approximately 40 staff supporting 40+ clinical trials ongoing at any given time with a typical volume of 1000 1500 echos received each month.

Working under the direction of the CICL Technical Director, the Clinical Trial Coordinator (CTC) will support day-to-day technical operations such as data analysis workflow, staff throughput, and other coordination activities associated with the CICL’s technical processes.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

Day-to-Day Study Operations :

• Provide clear and consistent organization of technical aspects of all CICL ongoing studies.This includes hands-on tasks such as tracking staff assignment, throughput, ensuring proper follow-up of pending project tasks and overseeing project timelines.
• Working closely with Technical Director, ensure smooth and efficient internal day-to-day technical operations related to echo analysis for all CICL ongoing studies.
• Communicate upcoming data transfers and ensure technical staff are aware and working towards timely data transfer.
• Assist the Technical Director and Quality Assurance Team with collecting, monitoring, and tracking technical onboarding documentation, and routine training documentation.
• Maintain appropriate document control standards per SOPs.

Data Management :

• Create and manage systems to track staff assignments and throughput.
• Monitor study-specific databases as needed to ensure efficient technical operations and site feedback.
• Responsible for generating both study-specific progress reports and data as well as generating center-wide cumulative data and progress reports as they relate to technical operations.

General :

• Work with CICL staff to enhance the technical reproducibility program. Assist the Technical Director with preparing documentation for this.
• Coordinate Technical team meetings, prepare agendas, track action items to completion, take and distribute minutes.
• Assist the Technical Director with document updates. Maintain final versions of technical documents and distribute to relevant technical team members.
• Other duties as assigned.

Qualifications

QUALIFICATIONS :

• BA / BS degree in health sciences, physiology or related field.
• Intermediate experience in Microsoft Office including Excel.
• 1-2 years of research-related experience preferred
• 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
• 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.

Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with

Databases

SUPERVISORY RESPONSIBILITIES :

None.

WORKING CONDITIONS :

The CICL supports a hybrid work model however in-office collaboration with CICL team members is required. This position is M-F during core business hours.

There is no patient interaction in this position.