Clinical Research Coordinator

Mass General BrighamBoston, MA
1d$24 - $39Onsite

About The Position

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. support new and ongoing cardiovascular clinical research trials Job Summary Summary Works independently under minimal supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cardiovascular studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Will have experience with institutional and federal regulations governing clinical research. In addition, +may assist management in the areas of Quality Control and Training & Development, and may provide input into the assessment of departmental procedures. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.

Requirements

  • Bachelor's Degree Related Field of Study required
  • Clinical Research or Compliance experience 1-2 years required
  • High level time management and organization skills.
  • Excellent written and verbal communication skills.
  • Knowledge of current and developing clinical research trends.
  • Sound interpersonal skills and the ability to mentor others.
  • Ability to work independently and display initiative.
  • Ability to identify problems and develop solutions.

Responsibilities

  • Identify changes associated with Standard Operating Procedures and develop procedure to ensure compliance.
  • Manage studies of a particular specialized program.
  • Pre-activation activities including pre-site qualification visits, SIVs, and facility tours.
  • Organize and prepare for internal/external audits.
  • Assist clinical team in screening potential patients for study participation.
  • Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
  • Obtain protocol clarifications from the study sponsor and communicate information to the research team.
  • Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
  • Schedule and prepare for monitoring visits with sponsors.
  • Provide upport of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out.
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