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Title: Drug Clinical Research Coordinator

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

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.