Research Coordinator

Title : Drug Clinical Research Coordinator Location : Boston MA Schedule : M-F (onsite daily) 8-5 Duration : 6 month contract to hire Pay Rate : $25-$30 / hr Start : ASAP Education : Bachelor’s Degree Requirements : 1-3 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 Be fluent in English and Spanish (preferred) Strong organizational skills with ability to multi-task Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions Assist Sr. Project Manager with documentation and follow up paperwork for the trial. Accomplished documentation skills with meticulous attention to detail Ability to complete tasks with aggressive deadlines and competing priorities Comfortable with hospital in-patient and out-patient environments Responsibilities : Assist Sr. Project Manager and team members with all phases of clinical research to include : Trial Initiation; Trial Coordination / Implementation / Maintenance and Trial Close-out Assist in development of trial protocol IRB application and submit to appropriate authority; Assist in the preparation and / or review budgets, coordinate and work with ancillary departments / services as needed to successfully execute protocol elements; assist in the plan for site initiation once IRB protocol approval is received. Working with a PA, conduct medical record screening of 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; Assist in maintaining 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) Assist with preparation and submission of final trial report to the IRB for review. Assist in the preparation of all documents / files / binders / electronic data for sponsor-initiated or FDA audits #m3 Ref : #558-Scientific