Clinical Research Associate
MGB Anesthesiology, Boston, MA, United States
Company Overview
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
The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. This position involves a high volume of data abstraction and data entry and does not include any direct patient contact.
Essential Functions
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 throughout the course of the study.
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to 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.
Participate in monitoring visits and maintain a record of all correspondence related to these visits.
Ensure adequate documentation of compliance and data integrity issues and respond appropriately.
Support effective communication between the clinical team, sponsor, and IRB, and report adverse events and deviations as required.
Responsibilities
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.
Monitor and report adverse events and deviations as required by sponsor, institution, and federal regulations.
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.
Schedule and prepare for monitoring visits with sponsors.
Organize and prepare for internal and external audits.
Maintain ongoing communication with the clinical team regarding study patients and progress for multiple studies.
Skills & Abilities
Careful attention to detail.
Good organizational skills.
Ability to follow directions.
Good communication skills.
Computer literacy.
Working knowledge of clinical research protocols.
Ability to demonstrate respect and professionalism for subjects’ rights and individual needs.
Qualifications
Education : Bachelor's Degree in a related field of study required. Experience in lieu of a degree may be accepted.
Experience: Research‑related experience preferred (1‑2 years).
Knowledge, Skills and Abilities: Attention to detail; recognition of compliance and data integrity issues; effective interpersonal and communication skills; ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Physical Requirements
Standing: Frequently (34‑66%)
Walking: Frequently (34‑66%)
Sitting: Occasionally (3‑33%)
Lifting: Frequently (34‑66%) 35 lbs+ (with assisted device)
Carrying: Frequently (34‑66%) 20‑35 lbs
Pushing: Occasionally (3‑33%)
Pulling: Occasionally (3‑33%)
Climbing: Rarely (Less than 2%)
Balancing: Frequently (34‑66%)
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
Hybrid work location: 101 Merrimac Street.
Pay Range
$20.16 – $29.01/Hourly (Grade 5).
Benefits
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.
EEO Statement
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.
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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
The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. This position involves a high volume of data abstraction and data entry and does not include any direct patient contact.
Essential Functions
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 throughout the course of the study.
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to 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.
Participate in monitoring visits and maintain a record of all correspondence related to these visits.
Ensure adequate documentation of compliance and data integrity issues and respond appropriately.
Support effective communication between the clinical team, sponsor, and IRB, and report adverse events and deviations as required.
Responsibilities
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.
Monitor and report adverse events and deviations as required by sponsor, institution, and federal regulations.
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.
Schedule and prepare for monitoring visits with sponsors.
Organize and prepare for internal and external audits.
Maintain ongoing communication with the clinical team regarding study patients and progress for multiple studies.
Skills & Abilities
Careful attention to detail.
Good organizational skills.
Ability to follow directions.
Good communication skills.
Computer literacy.
Working knowledge of clinical research protocols.
Ability to demonstrate respect and professionalism for subjects’ rights and individual needs.
Qualifications
Education : Bachelor's Degree in a related field of study required. Experience in lieu of a degree may be accepted.
Experience: Research‑related experience preferred (1‑2 years).
Knowledge, Skills and Abilities: Attention to detail; recognition of compliance and data integrity issues; effective interpersonal and communication skills; ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Physical Requirements
Standing: Frequently (34‑66%)
Walking: Frequently (34‑66%)
Sitting: Occasionally (3‑33%)
Lifting: Frequently (34‑66%) 35 lbs+ (with assisted device)
Carrying: Frequently (34‑66%) 20‑35 lbs
Pushing: Occasionally (3‑33%)
Pulling: Occasionally (3‑33%)
Climbing: Rarely (Less than 2%)
Balancing: Frequently (34‑66%)
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
Hybrid work location: 101 Merrimac Street.
Pay Range
$20.16 – $29.01/Hourly (Grade 5).
Benefits
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.
EEO Statement
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.
#J-18808-Ljbffr