Clinical Research Associate

Mass General Brigham Incorporated; Boston, Northern (MA, KY); Hybrid; USD 28,000 - 40,000; Full time

Job summary

Mass General Brigham in Boston is seeking a Clinical Research Associate to support regulatory compliance for clinical trials. You will collaborate with clinical teams, IRB, sponsors, and federal regulators, and gain training on institutional and federal regulations governing research.

Responsibilities include maintaining regulatory binders, submitting amendments and safety reports, updating consent documents, and tracking adverse events throughout studies.

Qualifications

• Bachelor's Degree in a Related Field required.
• Research-Related Experience 1–2 years preferred.
• Attention to detail; ensures data integrity and compliance.
• Able to recognize compliance and data integrity issues and respond appropriately.
• Working knowledge of clinical research protocols.
• Able to communicate effectively with patients, vendors, CROs, and staff.

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk information and protocol updates.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors.
• Collect, complete, and submit essential regulatory documents to various entities.
• Participate in monitoring visits and maintain records of communications.

Skills

Attention to detail

Compliance awareness

Clinical trial protocols

Effective communication

Education

Bachelor's Degree in a Related Field

Job description

## Clinical Research AssociateApply: Hybrid: Boston-MA: Full time: Posted Today: RQ4078721Site: The General Hospital CorporationMass 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**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 Clinical Research Associate will be trained on the institutional and federal regulations governing clinical research. Essential Functions: -Maintain and organize study-specific regulatory binders. -Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB. -Revise informed consent documents to include new risk information and/or updated protocol requirements throughout the course of the study. -Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. -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**Education:* Bachelor's Degree in a Related Field of Study requiredExperience:* Research-Related Experience 1-2 years preferredKnowledge, Skills and Abilities:* Attention to detail.* 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.* Effective interpersonal and communication skills.**Additional Job Details (if applicable)****Remote Type**Hybrid**Work Location**55 Fruit Street**Pay Range**$20.16 - $29.01/Hourly**Grade**5At 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:**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 (857)-282-7642.