Clinical Research AssociateClinical Research Coordinator I (Biopsy Project)

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 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.

Education
Bachelors 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.

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%)

Onsite

55 Fruit Street

40

Regular

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 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.

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 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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