Mass General Brigham

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 Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate II. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.

The Clinical Research Associate II (CRA II) works independently under general supervision to enroll eligible patients to clinical research protocols, maintain electronic research files for all enrolled patients and manage data collection for multiple cancer studies. The CRA II will be the liaison between the clinical team and the clinical trials sponsor(s), reaching out for clarifications, if needed, to ensure compliance with protocol requirements and will facilitate and manage study monitoring expectations in collaboration with the team’s regulatory coordinator. Effective management of communications is key to this role. The CRA II will have experience with 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 II will perform the following data management and other duties independently 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 electronic research 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
• Facilitate the request and shipment of archival pathology samples
• Organize and prepare for internal and external audits
• Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
• 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 investigators and sponsors throughout the clinical trial process
• 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

Tasks assigned to this role will be updated and/or changed as required to support the clinical research team

Qualifications

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Ability to work independently and as a team member
• Analytical skills and ability to resolve problems
• Adaptable and willing to take on new tasks as needed, to support the research team
• Ability to interpret acceptability of data results
• Careful attention to detail
• Good organizational and communication skills
• High degree of computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects’ rights and individual needs

Additional Job Details (if applicable)

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS

• None

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• Minimum of 1-2 years of related experience required.

SUPERVISORY RESPONSIBILITY:

• None

FISCAL RESPONSIBILITY :

• None

WORKING CONDITIONS:

Duties will be performed in the remote work setting

Remote Type

Remote

Work Location

2014 Washington Street

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

EEO Statement:

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.

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, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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