Brigham and Women’s Hospital
Clinical Research Coordinator I BWH CVD TIMI
Brigham and Women’s Hospital, Boston, Massachusetts, us, 02298
Job Description - Clinical Research Coordinator I BWH CVD TIMI (3310697)
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 comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.
Responsibilities:
Ongoing support:
Support TIMI investigators with all phases of clinical research including Trial Initiation, Trial Coordination/Implementation/Maintenance, and Trial Close-out. Trial Initiation:
Assist in the development of trial protocol IRB application and submit to the appropriate authority; prepare and/or review budgets; coordinate and work with ancillary departments/services; develop a 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; maintain accurate case report forms and trial records; schedule and conduct follow-up visits; obtain and process biological samples; co-manage trial medications; perform data entry; submit study documentation in a timely manner; notify sponsors and IRB of all pertinent AEs and SAEs; review completeness and quality of data; and educate ancillary staff regarding trial protocols. Trial Close-out:
Assist with preparation and submission of final trial report to the IRB; prepare all documents/files for audits. Other:
Maintain department service standards as outlined in the BWH Code of Conduct; perform other duties as required. Qualifications: Bachelor’s Degree 1-2 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 Skills: Fluency in English and Spanish (preferred) Excellent interpersonal skills and ability to work effectively in team environments Strong organizational skills with the ability to multi-task Good judgment skills with the ability to interpret information and protocol requirements Superior written and oral communication skills 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 Work Location:
MA-Boston-BWH Longwood Medical Area Schedule:
Full-time, Standard Hours 40, Day Job Employee Status:
Regular
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Support TIMI investigators with all phases of clinical research including Trial Initiation, Trial Coordination/Implementation/Maintenance, and Trial Close-out. Trial Initiation:
Assist in the development of trial protocol IRB application and submit to the appropriate authority; prepare and/or review budgets; coordinate and work with ancillary departments/services; develop a 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; maintain accurate case report forms and trial records; schedule and conduct follow-up visits; obtain and process biological samples; co-manage trial medications; perform data entry; submit study documentation in a timely manner; notify sponsors and IRB of all pertinent AEs and SAEs; review completeness and quality of data; and educate ancillary staff regarding trial protocols. Trial Close-out:
Assist with preparation and submission of final trial report to the IRB; prepare all documents/files for audits. Other:
Maintain department service standards as outlined in the BWH Code of Conduct; perform other duties as required. Qualifications: Bachelor’s Degree 1-2 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 Skills: Fluency in English and Spanish (preferred) Excellent interpersonal skills and ability to work effectively in team environments Strong organizational skills with the ability to multi-task Good judgment skills with the ability to interpret information and protocol requirements Superior written and oral communication skills 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 Work Location:
MA-Boston-BWH Longwood Medical Area Schedule:
Full-time, Standard Hours 40, Day Job Employee Status:
Regular
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