Boston, MA, USA
7 days ago
Clinical Research Coordinator 1
Site: The General Hospital Corporation


 

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community.  We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.


 


 

Job Summary

Working as a part of the Site at the Neurological Clinical Research Institute (NCRI), and working in collaboration with the multidisciplinary team, the incumbent will be responsible for supporting all aspects of clinical research coordination for studies at the NCRI. The research trials may include treatment trials, biomarker trials, imaging trials, and other research. The incumbent will be responsible for generating reports and maintaining records related to the assigned research studies. The incumbent will also provide administrative support to the professional and support staff of the NCRI, which may include providing support in the Amyotrophic Lateral Sclerosis (ALS) Clinic.


 

Qualifications

Primary Responsibilities include but not limited to:

Coordinates all activities of the subjects participating in the individual research studies such as scheduling patients for research study and collecting, organizing, and documenting the patient data from the visit.Maintains records and databases.Assists with recruiting patients for clinical trials.Obtains patient study data from medical records, physicians, etc.Verifies accuracy of study forms.Updates study forms per protocol.Prepares data for analysis and data entryAssists with regulatory binders and QA/QC proceduresAdministers and scores questionnaires.Provides a basic explanation of the study and in some cases obtains informed consent from subjects.Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.Draft consent forms.Corresponds with the Institutional Review Board (IRB) for approval of protocol, notification of adverse events, continuation of study, annual reporting of studies, and submission of amendments.Assists professional staff with patient treatment according to study guidelines. For example, arranges specific blood draws; performs phlebotomy; processes fluids; records medical histories; and sets up room for study-specific procedures.Knows their primary study thoroughly so that they can answer questions (from study staff and patients) accordingly such as timing of tests or protocol required lab orders.Assures investigators receive results of tests, as appropriate.Provides, creates, and maintains record-keeping systems: data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).Data entry of information into study databases.Communicate with the study sponsor including scheduling/conducting monitoring visits.Works cooperatively with the study sponsor to ensure that good clinical practices are being followed.Interacts internally with other hospital departments such as Dieticians, Harvard Catalyst CRC, Pharmacy, and Environmental Services as needed, and externally with personnel of regulatory agencies.Performs other administrative support duties as assignedAccepts responsibilities for special projects as requested.Other job-related duties as required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

Conduct appropriate decorum with direct contact with a terminal patient populationAbility to multitask.Careful attention to detailsGood organization skillsAbility to follow directionsExcellent verbal and written communication skills.Able to work with deadlines and at times stressful environments.Computer literacyAbility to interact well with others and work well, as a part of a team, with minimal supervision a must.

EDUCATION:

Bachelor's degree required

EXPERIENCE:

Relevant course work or project work.

An understanding of federal regulations (i.e. FDA, CFR, etc.), IRB review process, informed consent, trial design, and data monitoring as well as good writing skills and editing skills a plus.

WORKING CONDITIONS:

Office work. May have a rotating 8-hour shift on Tuesdays between 7:30 am and 6:30 pm. May travel. Exposure to dry ice and -80-degree freezers. May have to lift up to 20 lbs and apply force to resist patients/subjects in hand-held dynamometry. May be exposed to bodily fluids, including blood, urine, and cerebral spinal fluid. May work at different MGH or MGB sites including Main Campus, Charles River Plaza, and Charlestown Navy Yard.

Prior experience working in clinical research a plus.


 

Additional Job Details (if applicable)


 

Remote Type

Onsite


 

Work Location

165 Cambridge Street


 

Scheduled Weekly Hours

40


 

Employee Type

Regular


 

Work Shift

Day (United States of America)


 

EEO Statement:

The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.


 

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.

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