Sobre este puesto de Clinical Research Coordinator I, Orthopaedic Oncology Service MGH en Mass General Brigham
Mass General Brigham · Presencial · 32 Fruit Street Boston (Yawkey Center)
Site: The General Hospital Corporation
responsible for obtaining regulatory approval at both the local and federal level for the service’s research endeavors. Additionally, the incumbent will act as primary contact for all of service’s research-related administration.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Study Design/Completion: The incumbent designs research protocols in conjunction with the PIs, providing critical input as to feasibility of study design and available resources. The incumbent ensures study designs that are compatible with clinical practices and may coordinate multi-center trials with NIH, FDA, industry, and private foundations. When required, the incumbent coordinates and implements research design process at multiple sites. The incumbent develops detailed protocol documents that meet federal/institutional standards. The incumbent serves as a resource for patients and study sponsor personnel.
The incumbent works directly with the MGB Human Research Committee and Institutional Review Board (IRB). In this role, the incumbent is responsible for writing IRB applications and serves as the day-to-day liaison to the IRB and Human Research Committee. This person must be able to work collaboratively with staff physicians to process studies and protocols as required.
The incumbent demonstrates understanding and knowledge of designated study protocols and methods of implementation.
The incumbent identifies and enrolls patients into research studies via the informed consent process and follows up with them at necessary time points, when applicable.
Data Management: The incumbent organizes, establishes, and maintains research databases and uses these databases to extract information for reports, papers, and general feedback to the study team. The incumbent collects, compiles, tabulates and analyzes research data. The incumbent ensures that data is entered in timely fashion into the database accurately, and reviews and analyzes significant data and statistics in the computer file. The incumbent works to ensure that appropriate quality control systems are in place to monitor the progress of data acquisition and to define new approaches to data management while ensuring quality and completeness of database and patients' files. The incumbent maintains all required records and serves as a resource to staff and patients in providing statistical information from the database. The incumbent is also responsible for submitting and maintaining Data/Material Use Agreements with external sites.
Quality: In this role, the incumbent is responsible for quality control, and works with both internal and external colleagues to ensure rigorous adherence to internal and external quality standards. The incumbent develops, writes, and promulgates the Division’s operations manuals. The incumbent ensures consistency of all regulatory documents, both internal to MGB and those from external sources – i.e., FDA, NIH, industry sponsors.
Manuscripts: The incumbent will assist the PI with writing manuscripts. Through this process, the incumbent will be highly involved with the editing of these manuscripts. The incumbent assists in writing and editing research publications, as well as performs independent literature searches and selects references for final publication. The incumbent prepares data and graphics and assists in presenting study findings to interested groups both within and outside of the hospital. The incumbent may be expected to attend scientific conferences to present study findings.
Training/Supervision: The incumbent is responsible for supervising the service’s research staff, including undergraduate student interns and medical students. In this role, the incumbent reviews work of trainees and serves as a resource for staff. The incumbent conducts on and off-site training sessions to appropriate audiences – including PI’s, Co-investigators, interns, and all relevant staff.
Research Finance: When studies involve funding from Sponsors, the incumbent is responsible for tracking and submitting study invoices to the sponsor, especially those that involve patient-related costs.
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.Hybrid32 Fruit Street40RegularDay (United States of America)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 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 Department of Orthopadic's Oncology Service team is seeking a Clinical Research Coordinator who will work with physicians, clinical nurses, and staff to identify and recruit eligible patients for clinical studies. They will beresponsible for obtaining regulatory approval at both the local and federal level for the service’s research endeavors. Additionally, the incumbent will act as primary contact for all of service’s research-related administration.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Study Design/Completion: The incumbent designs research protocols in conjunction with the PIs, providing critical input as to feasibility of study design and available resources. The incumbent ensures study designs that are compatible with clinical practices and may coordinate multi-center trials with NIH, FDA, industry, and private foundations. When required, the incumbent coordinates and implements research design process at multiple sites. The incumbent develops detailed protocol documents that meet federal/institutional standards. The incumbent serves as a resource for patients and study sponsor personnel.
The incumbent works directly with the MGB Human Research Committee and Institutional Review Board (IRB). In this role, the incumbent is responsible for writing IRB applications and serves as the day-to-day liaison to the IRB and Human Research Committee. This person must be able to work collaboratively with staff physicians to process studies and protocols as required.
The incumbent demonstrates understanding and knowledge of designated study protocols and methods of implementation.
The incumbent identifies and enrolls patients into research studies via the informed consent process and follows up with them at necessary time points, when applicable.
Data Management: The incumbent organizes, establishes, and maintains research databases and uses these databases to extract information for reports, papers, and general feedback to the study team. The incumbent collects, compiles, tabulates and analyzes research data. The incumbent ensures that data is entered in timely fashion into the database accurately, and reviews and analyzes significant data and statistics in the computer file. The incumbent works to ensure that appropriate quality control systems are in place to monitor the progress of data acquisition and to define new approaches to data management while ensuring quality and completeness of database and patients' files. The incumbent maintains all required records and serves as a resource to staff and patients in providing statistical information from the database. The incumbent is also responsible for submitting and maintaining Data/Material Use Agreements with external sites.
Quality: In this role, the incumbent is responsible for quality control, and works with both internal and external colleagues to ensure rigorous adherence to internal and external quality standards. The incumbent develops, writes, and promulgates the Division’s operations manuals. The incumbent ensures consistency of all regulatory documents, both internal to MGB and those from external sources – i.e., FDA, NIH, industry sponsors.
Manuscripts: The incumbent will assist the PI with writing manuscripts. Through this process, the incumbent will be highly involved with the editing of these manuscripts. The incumbent assists in writing and editing research publications, as well as performs independent literature searches and selects references for final publication. The incumbent prepares data and graphics and assists in presenting study findings to interested groups both within and outside of the hospital. The incumbent may be expected to attend scientific conferences to present study findings.
Training/Supervision: The incumbent is responsible for supervising the service’s research staff, including undergraduate student interns and medical students. In this role, the incumbent reviews work of trainees and serves as a resource for staff. The incumbent conducts on and off-site training sessions to appropriate audiences – including PI’s, Co-investigators, interns, and all relevant staff.
Research Finance: When studies involve funding from Sponsors, the incumbent is responsible for tracking and submitting study invoices to the sponsor, especially those that involve patient-related costs.
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
Experience
Some relevant research project work 0-1 year preferred
Knowledge, Skills and Abilities:
- The incumbent must be able to and comfortable with working in clinical settings and the operating room.
- 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)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$21.00 - $29.01/Hourly
Grade
5
EEO Statement:
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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