Mass General Brigham
Site: The Brigham and Women's Hospital, Inc.
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 TIMI Research Coordinator is responsible for coordinating human clinical research activities for multiple clinical trials involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess the ability to work independently in all phases of human clinical research and must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities
Ongoing support of TIMI investigators with all phases of clinical research to include Trial Initiation, Trial Coordination/Implementation/Maintenance, and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in‑patients and out‑patients to identify eligible potential trial subjects; approach potential subjects and/or family members with trial‑specific information; assist in recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow‑up trial visits; obtain and process biological samples according to protocol; co‑manage with pharmacy all trial medications, including receipt and delivery; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit amendments to protocol or informed consent form(s) to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co‑investigator(s) on a daily basis of overall trial progress including subject enrollment, scheduling, issues/problems, subject retention, and lost to follow‑up metrics; submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols; develop trial materials as needed; orient and train new staff. Trial Close‑out: Assist with preparation and submission of final trial report to the IRB for review; prepare all documents/files/binders/electronic data for sponsor‑initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct and perform other duties as required. Qualifications
Bachelor’s Degree Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred Knowledge of federal and institutional policies governing human clinical research Proficiency with PCs and Windows‑based software, including Word, Excel, and data management systems Fluency in English and Spanish (preferred) Excellent interpersonal skills and ability to work effectively in team environments Strong organizational skills with ability to multi‑task Good judgment skills with ability to interpret information and protocol requirements and initiate appropriate actions Superior written and oral communication skills for working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds Accomplished documentation skills with meticulous attention to detail Ability to complete tasks with aggressive deadlines and competing priorities Ability to safeguard confidential information Comfortable with hospital in‑patient and out‑patient environments Clinical Research or Compliance experience 3–5 years required Exceptional time management and organization skills Knowledge of current and developing clinical research trends Sound interpersonal skills and ability to mentor others Ability to identify problems and develop solutions Demonstrated ability to successfully manage multiple projects EEO Statement
Partners HealthCare is an Equal Opportunity 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. Job Details
Remote Type: Onsite Work Location: 350 Longwood Avenue Scheduled Weekly Hours: 40 Employee Type: Regular Work Shift: Day (United States of America) Pay Range: $49,504.00 - $72,404.80/Annual
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The TIMI Research Coordinator is responsible for coordinating human clinical research activities for multiple clinical trials involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess the ability to work independently in all phases of human clinical research and must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities
Ongoing support of TIMI investigators with all phases of clinical research to include Trial Initiation, Trial Coordination/Implementation/Maintenance, and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in‑patients and out‑patients to identify eligible potential trial subjects; approach potential subjects and/or family members with trial‑specific information; assist in recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow‑up trial visits; obtain and process biological samples according to protocol; co‑manage with pharmacy all trial medications, including receipt and delivery; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit amendments to protocol or informed consent form(s) to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co‑investigator(s) on a daily basis of overall trial progress including subject enrollment, scheduling, issues/problems, subject retention, and lost to follow‑up metrics; submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols; develop trial materials as needed; orient and train new staff. Trial Close‑out: Assist with preparation and submission of final trial report to the IRB for review; prepare all documents/files/binders/electronic data for sponsor‑initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct and perform other duties as required. Qualifications
Bachelor’s Degree Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred Knowledge of federal and institutional policies governing human clinical research Proficiency with PCs and Windows‑based software, including Word, Excel, and data management systems Fluency in English and Spanish (preferred) Excellent interpersonal skills and ability to work effectively in team environments Strong organizational skills with ability to multi‑task Good judgment skills with ability to interpret information and protocol requirements and initiate appropriate actions Superior written and oral communication skills for working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds Accomplished documentation skills with meticulous attention to detail Ability to complete tasks with aggressive deadlines and competing priorities Ability to safeguard confidential information Comfortable with hospital in‑patient and out‑patient environments Clinical Research or Compliance experience 3–5 years required Exceptional time management and organization skills Knowledge of current and developing clinical research trends Sound interpersonal skills and ability to mentor others Ability to identify problems and develop solutions Demonstrated ability to successfully manage multiple projects EEO Statement
Partners HealthCare is an Equal Opportunity 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. Job Details
Remote Type: Onsite Work Location: 350 Longwood Avenue Scheduled Weekly Hours: 40 Employee Type: Regular Work Shift: Day (United States of America) Pay Range: $49,504.00 - $72,404.80/Annual
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