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.

The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects, including the Breast Biopsy Project. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work. The position involves direct patient contact daily.

All duties will be performed under general supervision by the Clinical Research Manager.

The following clinical duties will be performed:

• Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients
• Coordinating the collection and processing of tissue samples and blood samples from patients, which can include being in the biopsy procedure room
• Consent patients to translational research studies (minimal risk specimen collection studies)
• Explain study protocol to patients and obtain informed consent
• Screen and follow patients relevant to specific projects/studies
• Assist clinical team in screening potential patients for study participation and coordinate with the clinical team to consent patients and collect tissue
• Schedule all protocol required tests and procedures
• Consent patients to specimen collection protocols
• Coordinate patient appointments with physicians, nurses, and all test areas
• Prepare pre-visit communication for providers to ensure required assessments are completed and documented
• Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation
• Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition
• Coordinate, obtain, process, and ship protocol required blood and tissue samples, specifically coordinating with a Lab
• Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)

The following data management responsibilities will be performed:

• Collecting detailed clinical and treatment information on patients who are undergoing screening for breast cancer, genetic testing, receiving treatments for cancer, or are enrolled in a research study
• Maintaining an updated and organized database of patients
• Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
• Enroll/register patients
• 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.
• 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
• Facilitate the request and shipment of samples
• Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
• Produce reports on the status of projects
• Assist in abstracts, presentations, and manuscripts

The following regulatory duties may be performed:

• Assist with new study submission
• Assist with updates and/or changes to current studies
• 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
• Maintain documentation of correspondence with the IRB, investigators, and the lab throughout the clinical trial process
• Collect, complete, and submit essential regulatory documents to various regulatory entities
• Ensure appropriate documentation of delegation and training for all study staff members
• Maintain screening and enrollment documentation
• Prepare monthly enrollment and data summary for study team

Job Summary:

Summary:

Works independently under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting.

Does this position require Patient Care?
No

Essential Functions
-Coordinate patient appointments with physicians, nurses, and all test areas.

-Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.

-Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all 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.

-Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.

-Collect, complete, and submit essential regulatory documents to various regulatory entities.

Qualifications:

Education:

Bachelor's Degree Related Field of Study required:

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials:

Experience:

Clinical Research or compliance experience 1-2 years preferred

• Knowledge, Skills and Abilities
• Ability to work independently and as a team member.
• Analytical skills and ability to resolve problems.
• Ability to interpret acceptability of data results.
• Careful attention to detail.
• Good organizational and communication skills.
• Working knowledge of clinical research protocols.

Additional Job Details (if applicable)

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision
• Far Constantly (67-100%)
• Vision
• Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Remote Type

Onsite

Work Location

55 Fruit Street

Scheduled Weekly Hours:

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$20.16 - $29.01/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 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.

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.