Clinical Trial Coordinator CICL - Per Diem

Site: The Brigham and Women's Hospital, Inc.

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

 

Job 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 (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.

 

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Day-to-Day Study Operations:

• Provides 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.
• Ensures 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.
• Serves 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.
• Maintains appropriate document control standards per SOPs.

Data Management:

• Assists with the creation of new, and management of existing CICL databases.
• Generates both study-specific progress reports and data as well as center-wide cumulative data and progress reports.
• Works 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:

• Facilitates 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.
• Advises research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
• Identifies issues/trends that require escalation to management and provide input to resolution as appropriate.
• Contributes to the preparation of the department/trial specific SOPs and working instructions in accordance with operations guidelines, sponsor protocol, FDA requirements, and audit procedures.
• Contributes to the identification and implementation of process improvement opportunities. Works with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
• Prepares official trial correspondence (i.e., numbered memos).  
• Understands audit trails and discoverable information.
• Collaborates with internal and external stakeholders.
• Assists and support other team members as needed.
• Maintains department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.
• Demonstrates and maintain knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department/trial(s).

QUALIFICATIONS:

• BA/BS degree in biological sciences or health administration.
• 1-2 y