Clinical Trial Coordinator

The General Hospital Corporation; Boston (MA); Híbrido; USD 45.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Descripción de la vacante

The Brigham and Women's Hospital, Inc. seeks a Research Project Coordinator to ensure trials meet protocol, GCP, and sponsor standards. Independent work under supervision, supporting one or more trials with day-to-day administrative activities.

Responsibilities include site communications, document collection, protocol interpretation guidance, and data tracking. Collaboration with project managers and monitors is essential in a hybrid work environment at 75 Francis Street.

Formación

• Bachelor's Degree in a related field is required.
• Experience in lieu of a degree is not accepted.

Responsabilidades

• 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.

Conocimientos

Organizational skills

Written communication

Verbal communication

Autonomy

Matrix collaboration

Task prioritization

Educación

Bachelor's Degree in Related Field

Herramientas

EDC

CTMS

Descripción del empleo

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

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.

Qualifications

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)

• Remote Type Hybrid
• Work Location 75 Francis Street
• Scheduled Weekly Hours 0
• Employee Type Per Diem
• Work Shift Day (United States of America)
• Pay Range $ - $39.43/Hourly
• Grade 6

EEO Statement

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.

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,