Clinical Trial Coordinator

Brigham and Women's Hospital, Inc.; Boston (MA); On-site; USD 34,000 - 54,000; Full time

Job summary

The Brigham and Women's Hospital, Inc. is seeking a Clinical Trial Coordinator to ensure trials are conducted per protocol, GCP, and sponsor standards.

You will work independently to support one or more trials, handling day-to-day project activities and coordinating with sites and monitors. Responsibilities include obtaining regulatory documents, reviewing site regulatory packages, maintaining study files, and preparing meeting materials.

Qualifications

• 1-2 years of research-related experience required.
• Familiarity with EDC and CTMS systems 2-3 years preferred.
• Excellent organizational and communication skills are essential.

Responsibilities

• Identify and initiate communications with sites to obtain regulatory documents.
• Collect and review essential regulatory documents for completeness prior to submission.
• Advise sites on protocol conduct and issue resolution.
• Update internal databases, tracking systems, project plans, and study files.
• Prepare materials for internal and external meetings; draft agendas and minutes.
• Support trial processes and distribution of information to monitors.
• Facilitate policy/process improvements for the department/trial.
• Comply with SOPs.

Skills

Organizational skills

Communication skills

Autonomy

Project coordination

Education

Bachelor's degree in related field

Tools

EDC

CTMS

Job description

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 SummaryResponsible 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?NoEssential 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.QualificationsEducationBachelor's Degree Related Field of Study requiredCan this role accept experience in lieu of a degree?NoLicenses and CredentialsExperienceResearch Related Experience 1-2 years required or Familiarity with EDC and CTMS systems 2-3 years preferredKnowledge, 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 TypeOnsiteWork Location75 Francis StreetScheduled Weekly Hours40Employee TypeRegularWork ShiftDay (United States of America)Pay Range$24.52 - $39.43/HourlyGrade6At 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.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 FrameworkAt 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.