Clinical Trial Coordinator CICL - Per Diem

Site: The Brigham and Womens Hospital Inc.

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Job Summary

The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Womens 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 ofechos 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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Day-to-Day Study Operations:

• Provides clear and consistent organization of each assigned trials 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 years of research-related experience preferred
• Highly proficient in MS Office
• 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.

SUPERVISORY RESPONSIBILITIES:

None.

WORKING CONDITIONS:

The CICL supports a hybrid work mode. This position requires in-office collaboration with CICL team members at least 3 days a week. This position is M-F during core business hours.

Hybrid

15 Francis Street

0

Per Diem

Day (United States of America)

The Brigham and Womens Hospital Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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