System One Clinical Trial Coordinator in Boston, Massachusetts
Title: Clinical Trial Coordinator
Location: Boston MA On Site Daily
Schedule: M-F 8:30 to 5:00pm on site with some flexibility
Duration: 6 month contract to hire
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
Coordinate human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities
Ability to work independently in all phases of human clinical research. Trial Initiation; Trial Coordination/ Implementation/ Maintenance and Trial Close-out
Comply with all regulatory requirements, NIH Guidelines, and HIPAA regulations.
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 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;
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);
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.
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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