Clinical Trial Coordinator

Mass General Brigham•Boston, MA

47d•Hybrid

About The Position

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 (echo) core laboratory services for primarily large-scale global clinical trials, responsible for site training and interface as well as quantitative 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 Operational Director and study-specific Project Manager, the Clinical Trial Coordinator (CTC) is an integral member of the CICL 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 CTC will interact with research collaborators within other Harvard departments, various Sponsors, CROs, and with enrolling sites around the world. 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.

Requirements

Bachelor's Degree Related Field of Study required
Research Related Experience 1-2 years required
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.

Nice To Haves

Familiarity with EDC and CTMS systems 2-3 years preferred

Responsibilities

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.