Site: The Brigham and Women's Hospital, Inc.
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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.
Summary
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.
Does this position require Patient Care?
No
Essential Functions
-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.
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Experience
Research Related Experience 1-2 years required or Familiarity with EDC and CTMS systems 2-3 years preferred
Knowledge, Skills and Abilities
- 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.
Additional Job Details (if applicable)
Hybrid
75 Francis Street
40
Regular
Day (United States of America)
Pay Range
$24.52 - $39.43/Hourly
Grade
6
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
2200 The Brigham and Women's 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 Veteran’s 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 (857)-282-7642.
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