Clinical Research Monitoring (CRA)

Clinical Research Regulatory Coordinator InvestigatorMass 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.Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.Maintain and organize study-specific regulatory binders.Revise informed consent documents to include new risk information and/or updated protocol requirements throughout the course of the study.Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.Collect, complete, and submit essential regulatory documents to various regulatory entities.Participate in monitoring visits and maintain a record of all correspondence related to these visits.Qualifications:Bachelor's Degree in a Related Field of Study requiredResearch-Related Experience 1-2 years preferredKnowledge, Skills and Abilities:Ability to recognize compliance and data integrity issues and respond appropriately.Working knowledge of clinical research protocols.Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.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. 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. EEO Statement:1200 The General Hospital Corporation 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 View phone number on click.appcast.io.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.