Clinical Research Coordinator II-Hosp & RI Factor Program

** Overview:
**** Job Description

Summary:

** Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.
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* Job Description:

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* Essential Functions:

*** Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
* Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations;
Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
* Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
* Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
* Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
* Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,
* Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
* Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
* Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
* Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
* Assists the principal investigator in the preparation of scientific publications and grant proposals.  
** Education Requirement:
*** Associate's degree or equivalent work-related experience, required.
* BA/BS, preferred.  
** Licensure Requirement:**(not specified)  
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* Certifications:

** CRA/CRC certification, preferred.  
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* Skills:

*** Understanding of medical terminology and clinical trials preferred.
* Working knowledge of PCs and word processing and data management software.
* Demonstrated analytical skills with accuracy and attention to detail.
* Excellent verbal and written communication skills.
* Goal-oriented and self-directive, ability to manage complex projects independently.
* Strong organizational and interpersonal skills.
* Ability to actively participate as a team player.  
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* Experience:

** Eighteen months experience in clinical research or health care field, required.  
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* Physical Requirements:

** OCCASIONALLY:
Cold Temperatures, Driving motor vehicles (work required)  
* additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel FREQUENTLY:
Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs,…