Clinical Research Associate I

Site: The General Hospital Corporation

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

General Summary/Overview Statement:

The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team sponsor and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.

Principal Duties and Responsibilities:
The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager:

Verify adequate documentation of consent required screening tests and procedures and eligibility criteria to ensure patients meet all inclusion/exclusion criteria

Enroll patients as required by the study sponsor and internal enrollment monitor team

Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance

Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.

Monitor and report adverse events and deviations as required by the sponsor institution and federal regulations

Maintain research charts and/or electronic files for all enrolled patients

Ensure adequate source documentation is in place for all data reported

Resolve data queries issued by the sponsor

Obtain protocol clarifications from the study sponsor and communicate information to the research team

Schedule and prepare for monitoring visits with sponsors

Organize and prepare for internal and external audits

Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies

The following regulatory duties may be performed under general supervision by the Clinical Research Manager:

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 through 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

Submit Data and Safety Monitoring Reports

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 file all monitoring visit correspondence

Ensure appropriate documentation of delegation and training for all study staff members

Maintain screening and enrollment logs

Skills/Abilities/Competencies Required

Careful attention to detail

Good organizational skills

Ability to follow directions

Good communication skills

Computer literacy

Working knowledge of clinical research protocols

Ability to demonstrate respect and professionalism for subjects rights and individual needs


Working Conditions:

Duties may be performed in a combination of on-site and remote work setting.

Education
Bachelors 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 preferred

Knowledge Skills and Abilities
- Attention to detail.
- Ability to recognize compliance and data integrity issues and respond appropriately.
- Knowledge of medical terminology.
- Ability to communicate effectively with patients vendors contract research organizations and professional staff.
- Effective interpersonal and communications skills.

Hybrid

101 Merrimac Street

Pay Range

$19.76 - $28.44/Hourly

Grade

5

At 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 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.

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 Veterans 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 .

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