Clinical Research 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
Summary
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; and maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification.

Does this position require Patient Care?
No

Essential Functions
-Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met.

-Recruiting patients for clinical trials and conducting phone interviews.

-Verifies the accuracy of study forms and updates them per protocol.

-Prepares data for analysis and data entry.

-Documents patient visits and procedures.

-Assists with regulatory binders and QA/QC Procedures.

-Assists with interviewing study subjects.

-Assists with study regulator submissions.

Qualifications

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Some relevant research project work 0-1 year preferred

Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.

Additional Job Details (if applicable)

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.

PRIMARY RESPONSIBILITIES:

- Coordinates all activities of subjects participating in individual research studies, including scheduling patients for research studies and collecting, organizing, and documenting patient data from each visit.
- Maintains records and databases.
- Assists with recruiting patients for clinical trials.
- Obtains patient study data from medical records, physicians, etc.
- Verifies the accuracy of study forms.
- Update study forms per protocol.
- Prepares data for analysis and data entry
- Assists with regulatory binders and QA/QC procedures
- Administers 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; sets up room for study-specific procedures.
- Knows their primary study thoroughly so that they are able to answer questions (from study staff and patients) accordingly, such as the timing of tests or the protocol required lab orders.
- Ensures 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 assigned
- Accepts 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 population
- Ability to multitask.
- Careful attention to details
- Good organizational skills
- Ability to follow directions
- Excellent verbal and written communication skills.
- Able to work with deadlines and in times of stressful environments.
- Computer literacy
- Ability to interact well with others and work well, as a part of a team, with minimal supervision a must.

EDUCATION:

Bachelor Degree required

EXPERIENCE:

Relevant coursework or project work.

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

WORKING CONDITIONS:

Office work. May have a rotating 8 hour shift on Tuesdays between 7:30am and 6:30pm. May travel. Exposure to dry ice and -80degree freezers. May have to lift up to 20lbs 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 Partners sites including Main Campus, Charles River Plaza, and Charlestown Navy Yard.

Remote Type
Onsite

Work Location
165 Cambridge Street

Scheduled Weekly Hours
40

Employee Type
Regular

Work Shift
Day (United States of America)

Pay Range
$21.00 - $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.