Senior Clinical Research Coordinator
Apply NowCompany: Mass General Brigham
Location: Boston, MA 02115
Description:
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
The MGH Crohn's and Colitis center in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Senior Clinical Research Coordinator (CRC) for management of clinical trials. This individual will be responsible for all study tasks related to data and sample collection for ongoing clinical trials including subject enrollment, capturing clinical data, scheduling, conducting study visits, processing biologic specimens and maintaining relationships with collaborators and sponsors. There will be a strong focus on regulatory start-up, patient recruitment and retention, as well as completing clinical trial related tasks.
The schedule may require some flexibility with earlier or later hours during the work week to accommodate patient schedules. An ideal candidate would possess a biology or data analysis background and also have a minimum of 3-5 years clinical research experience. Prior experience with clinical trial management and execution and/or experience with regulatory or project management experience would be strongly preferred.
This position offers the opportunity to work directly with a motivated patient population, and expert physicians and learn the basics about clinical trials in a large academic medical center. It offers tremendous potential for growth in the medical, pharmaceutical, or regulatory affairs fields.
Qualifications
Clinical Trial Responsibilities
Skills/Abilities/Competencies Required:
Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results
Highly motivated, self-directed and driven to meet study goals
Excellent communication skills and willing to assume study leadership role
Ability to manage time independently, effectively and efficiently
Ability to juggle multiple tasks, people and schedules.
High degree of computer literacy, knowledge of Microsoft Office suite
Ability to demonstrate professionalism and respect for subjects' rights and individual needs
Must have the ability to prepare and monitor budgets, to identify problems and develop solutions, prioritize tasks and set deadlines.
Experience:
Supervisory Responsibilities:
This position may have oversight of other CRC I/IIs as needed. This could include assistance with the orientation and training of new coordinators, under direction of the PI.
Fiscal Responsibility:
Study coordinator will be responsible for submitting and tracking sponsor invoices for milestone payments. In coordination with the research grant manager, CRC will review and reconcile study funds against invoices and follow-up on outstanding payments. CRC will also allocate patient bills to clinical trial funds.
Additional Job Details (if applicable)
Physical Requirements
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.
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
The MGH Crohn's and Colitis center in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Senior Clinical Research Coordinator (CRC) for management of clinical trials. This individual will be responsible for all study tasks related to data and sample collection for ongoing clinical trials including subject enrollment, capturing clinical data, scheduling, conducting study visits, processing biologic specimens and maintaining relationships with collaborators and sponsors. There will be a strong focus on regulatory start-up, patient recruitment and retention, as well as completing clinical trial related tasks.
The schedule may require some flexibility with earlier or later hours during the work week to accommodate patient schedules. An ideal candidate would possess a biology or data analysis background and also have a minimum of 3-5 years clinical research experience. Prior experience with clinical trial management and execution and/or experience with regulatory or project management experience would be strongly preferred.
This position offers the opportunity to work directly with a motivated patient population, and expert physicians and learn the basics about clinical trials in a large academic medical center. It offers tremendous potential for growth in the medical, pharmaceutical, or regulatory affairs fields.
Qualifications
Clinical Trial Responsibilities
- Manage study operations and ensure integrity of study
- Facilitate IRB submission process by preparing protocol applications, protocol amendments, safety reports, and other required documents.
- Manage and maintain regulatory documents for audit by sponsor or FDA.
- Assist recruitment and/or randomization of subjects per study protocol
- Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol
- Assess subject's health through interviews; take subjects vital signs
- Perform phlebotomy (if certified) on subjects; process and ship specimens
- Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject's primary care provider
- Maintain subject charts and other data per the protocol and assess data for quality and completeness
- Conduct ongoing review of study progress and provide investigators with progress reports
- Coordinate and facilitate site sponsor visits
Skills/Abilities/Competencies Required:
Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results
Highly motivated, self-directed and driven to meet study goals
Excellent communication skills and willing to assume study leadership role
Ability to manage time independently, effectively and efficiently
Ability to juggle multiple tasks, people and schedules.
High degree of computer literacy, knowledge of Microsoft Office suite
Ability to demonstrate professionalism and respect for subjects' rights and individual needs
Must have the ability to prepare and monitor budgets, to identify problems and develop solutions, prioritize tasks and set deadlines.
Experience:
- Minimum 3-5 years full time research experience in a clinical setting required. Experience in investigation drug studies strongly preferred.
- Minimum 1 year of industry sponsored clinical trial experience and IND application experience required.
- Biology and/or laboratory science background preferred, but not required
- Biostatistics background preferred, but not required
Supervisory Responsibilities:
This position may have oversight of other CRC I/IIs as needed. This could include assistance with the orientation and training of new coordinators, under direction of the PI.
Fiscal Responsibility:
Study coordinator will be responsible for submitting and tracking sponsor invoices for milestone payments. In coordination with the research grant manager, CRC will review and reconcile study funds against invoices and follow-up on outstanding payments. CRC will also allocate patient bills to clinical trial funds.
Additional Job Details (if applicable)
Physical Requirements
- Standing Frequently (34-66%)
- Walking Frequently (34-66%)
- Sitting Occasionally (3-33%)
- Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
- Carrying Frequently (34-66%) 20lbs - 35lbs
- Pushing Occasionally (3-33%)
- Pulling Occasionally (3-33%)
- Climbing Rarely (Less than 2%)
- Balancing Frequently (34-66%)
- Stooping Occasionally (3-33%)
- Kneeling Occasionally (3-33%)
- Crouching Occasionally (3-33%)
- Crawling Rarely (Less than 2%)
- Reaching Frequently (34-66%)
- Gross Manipulation (Handling) Frequently (34-66%)
- Fine Manipulation (Fingering) Frequently (34-66%)
- Feeling Constantly (67-100%)
- Foot Use Rarely (Less than 2%)
- Vision - Far Constantly (67-100%)
- Vision - Near Constantly (67-100%)
- Talking Constantly (67-100%)
- Hearing Constantly (67-100%)
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.