Clinical Research Associate/Coordinator 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

The Cancer Center Protocol Office is seeking motivated detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. 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/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team sponsor and Institutional Review Board (IRB) to ensure appropriate communication and reporting. 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.

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

The following clinical duties will be performed:

Assist clinical team in screening potential patients for study participation

Schedule all protocol required tests and procedures

Coordinate patient appointments with physicians nurses and all test areas

Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers

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 tissue samples

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)

Obtain vital signs and perform EKGs as required for individual studies

Administer quality of life assessments as required for individual studies

The following data management responsibilities will be performed:

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

Facilitate the request and shipment of archival pathology samples

Organize and prepare for internal and external audits

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

The following regulatory duties may be performed:

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

EDUCATION:

BA/BS degree required

WORKING CONDITIONS:

Duties will be performed primarily on-site in an ambulatory/clinical office setting

Components of the data/regulatory role may allow for remote work.

Onsite

55 Fruit Street

40

Regular

Day (United States of America)

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 .

Mass General Brigham Competency Framework