Senior Clinical Research Coordinator

Mass General Brigham • Boston, MA

23h • Onsite

About The Position

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. to support new cardiovascular clinical trials 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 ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.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 ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.

Requirements

• 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 system
• Excellent interpersonal skills and ability to work effectively in team environments.
• Strong organizational skills with ability to multi-task
• Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions
• Superior written and oral communication skills, to enable 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
• Exceptional time management and organization skills.
• Excellent written and verbal communication skills.
• Knowledge of current and developing clinical research trends.
• Sound interpersonal skills and the ability to mentor others.
• Ability to identify problems and develop solutions.
• Demonstrated ability to successfully manage multiple projects.

Nice To Haves

• Be fluent in English and Spanish (preferred)

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; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the 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 (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; 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 any 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, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, 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; and 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. Perform other duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level