Clinical Trial Coordinator BWH Cardiovascular at Partner's Healthcare in Boston, Massachusetts

Posted in Other 1 day ago.





Job Description:

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


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.



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 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.



Qualifications



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:




  • 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






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.



Additional Job Details (if applicable)


Additional Job Description



Remote Type


Hybrid



Work Location


75 Francis Street



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


The Brigham and Women's Hospital, Inc. is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.



Mass General Brigham Competency Framework


At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
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