Position Details: V01010-0003: Clinical Research Coordinator

Location:	Most major US Cities, Multiple States
Openings:	13
Salary Range:

Description:

Our client has an exciting opportunity for a clinical research associate coordinator. To work as an integral member of the investigational site team co-ordinating clinical studies in accordance with the protocol and sponsor/Quintiles SOPs to the standard defined in the relevant Good Clinical Research Practice / ICH Guidelines, the local and Regulatory Codes of Professional Conduct.

Responsibilities:

Work directly at patient/subject interface at investigational sites to deliver high quality patient data in accordance with regulations and as required by the study protocol.
Participate in the recruitment and screening of research participants.
Design and maintain organizational tools to conduct the research study accurately in compliance with good clinical practice guidelines.
Responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data. collection and query resolution.
Collection, preparation and submission of regulatory documents.
Attendance at and participation in investigator meetings, seminars and other regional or national research meetings.
Participation in study monitor site visits.
Assist investigator in obtaining proper written consent from each study participant according to FDA Guidelines
Performance of functions necessary for completion of all research protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits.
Completion and corrections of case report forms ensuring accuracy of all records connected with each research participant.
Completion of accurate source documents and communication records.
Report and record all adverse events according to GCP-FDA Guidelines and the request of the sponsor.
Knowledgeable of protocol so that all study activities are correctly completed.
Maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients.
Maintain close contact with each sponsor or pharmaceutical company concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events.
Performs other duties as required.

Qualifications:

BA/BS in a Scientific or Healthcare or RN plus 2 years clinical research coordination experience or the equivalent of education, experience or training.
Must have a sound knowledge of medical terminology
Above average interpersonal and organizational skills.
Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment
Proficient computer skills including WordPerfect, MS Word, Excel and PowerPoint
Clinical research experience and ACRP certification preferred

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Position Details: V01010-0003: Clinical Research Coordinator

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