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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.

replacement as employee in current position is relocating

Job Summary:

The Research Assistant II will be involved in coordinating the clinical research activities and quality improvement data management and analysis for the Cardiac Intensive Care Unit (CICU) of the Cardiovascular Division at Brigham and Women’s Hospital. The candidate must possess ability to work independently in all phases of clinical research. Must comply with hospital regulatory requirements, NIH Guidelines, and HIPAA regulations.

Qualifications:

Responsibilities include supporting CICU investigators in all of the stages of clinical research: including research initiation, regulatory (IRB) submission, care coordination of subjects, required education of staff, maintenance and adherence to the protocol, monitoring of data, reporting to both sponsor and IRB until close-out of each study.  In addition, the Coordinator will also devote substantial effort to managing data collection and analysis for selected quality improvement initiatives linked to the CICU.  The Coordinator will function in the co-management of clinical research and CICU database activities with the CICU Director and investigators. Principal responsibilities include but are not limited to:

• Develops, implements, and maintain databases (e.g. REDCap, Study Trax) for CICU-based projects
• Oversees the project database data management, data collection, and data quality. Reviews and analyzes data to ensure consistency, integrity, and accuracy based on project specific guidelines
• Responsible for creating data reports and presents regular and ad-hoc study progress reports for weekly meetings, and study sponsors.
• Participates in regular meeting with QI and project teams
• Contributes to preparation of abstracts and manuscripts for publication.
• Actively responsible for the recruitment of study subjects. This includes developing and implementation of recruitment strategies, telephone screening of potential subjects, enlisting participation by scheduling appointments and sending out necessary paperwork.
• Performing study visits, including administration of consent, following procedures for study visits, and appropriate follow up with subjects.
• Collects and reviews study data, ensuring compliance with protocol and data integrity. Maintain case report forms, regulatory binders, perform follow-up contacts, and maintain meticulous study records.  Obtain and process biological samples according to protocol after completing any necessary training.
• Drafts corrective action plans for any issues identified through QC. Ensures queries are responded to in a timely manner.
• Oversees regulatory aspects of trials, including monitoring or coordinating a monitoring body, safety and protocol violation documentation as appropriate. Develops and prepares content for study IRB submissions, amendments, continuing reviews, and reports.   Ensures audit-ready files are kept.
• Serves as the primary contact for assigned projects for both internal and external communications. Directly responds to inquiries regarding study protocol and policy. Ensures necessary meetings are held and minutes kept and distributed. Hosts site visits. Negotiates study timelines and keeps team members accountable.

Education:

Bachelor's Degree Science required:

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials:

Experience:

Cardiovascular experience required.

Relevant research and data management experience 1-2 years required

• Knowledge, Skills and Abilities
• Good interpersonal and communication skills.
• Careful attention to detail.
• Excellent organizational skills and ability to prioritize a variety of tasks.
• Intermediate computer literacy including database tools.
• Knowledge of data management programs.
• Ability to follow directions and exhibit professionalism, and work more independently.

Additional Job Details (if applicable)Remote Type
Onsite

Work Location
350 Longwood Avenue

Scheduled Weekly Hours:

40

Employee Type
Regular

Work Shift
Day (United States of America)

Pay Range
$24.28 - $39.43/Hourly

Grade
6

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 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: Balance Sheet Cost Centers 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.