Clinical Research AssociateCoordinator 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.

GENERAL SUMMARY/ OVERVIEW STATEMENT:

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. 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.

Job Summary

PRINCIPAL DUTIES AND RESPONSIBILITIES:



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

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

Schedule all protocol required tests and procedures

Consent patients to specimen collection protocols

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 blood and 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)



The following data management responsibilities will be performed:

Collecting detailed clinical and treatment information on patients who are undergoing 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 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.

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

Facilitate the request and shipment of samples

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

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 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

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



SKILLS/ABILITIES/COMPETENCIES REQUIRED:

Ability to be self-motivated to work independently and as a team member

Analytical skills and ability to resolve problems

Careful attention to detail

Excellent organizational skills

Ability to follow directions

Excellent verbal and written communication skills

Computer literacy

Working knowledge of clinical research protocols

Ability to demonstrate respect and professionalism for subjects rights and individual needs

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.

WORKING CONDITIONS:

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

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

Hybrid

101 Merrimac Street

40

Regular

Day (United States of America)

Pay Range

$19.76 - $28.44/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.

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