Clinical Research Coordinator

Research department within busy GI office is seeking a full-time Clinical Research Coordinator.  The CRC coordinates all aspects of the research trial which includes procedures such as blood draws.  The CRC has a detailed understanding of the study protocol and relevant procedures needed to carry out the study.  Industry clinical research experience preferred and hours vary based on subject schedule and clinic hours.

Duties and Responsibilities

The CRC will conduct study visits and execute all aspects of the study protocol, including, but not limited to:

• Plan, implement and coordinate all aspects of data collection and source documentation as per GCP/ICH guidelines
• Design and maintain subject source documents
• Review subject source documents, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
• Confer with subject and physician to explain purpose of study. Explain diagnostic procedures and method of treatment to answer subject concerns.
• Obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
• Coordinates study visit schedules for inpatient and outpatient study subjects
• Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials.
• Dispense investigational medication as required by the protocol
• Educate the subjects on the use of investigational product
• Maintain accurate case histories of each study subject
• Obtain and accurately document adverse events and concomitant medications in the source documents and eCRF/CRF
• Obtain and coordinate subject blood samples and other specimens for laboratory analysis as described in study protocol.
• Collect pertinent information and data from subject charts and records, subject interviews, and other sources.
• Inspect eCRF/CRFs, source documentation, and study files to ensure completeness.
• Complete study visit source and enter into eCRF/CRF  in a timely manner and according to site standard operating procedures. 
• Review eCRF/CRFs, source documentation, and study files with representative from sponsor, IRB, or Food and Drug Administration (FDA) at designated visit. Make necessary corrections to eCRF/CRFs and submit requested documentation in a timely manner.
• Assists the sponsor in interim monitoring visits which includes query resolution and monitor interaction during site visits
• Communicates effectively with site monitor and medical monitor as needed for resolution to study related concerns
• Comply with standard operating procedures of the sponsor, institutional review board (IRB), and the Accurate Clinical Trials research site.
• Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and research site as necessary
• Provide training and direction to assistants or new personnel on protocol procedures. 

Qualifications

• RN, LPN, medical assistant, or person with medically related or research experience
• One year experience in a mental health or research environment to allow familiarity with basic medical and research terminology and procedures
• Detail-oriented person with the ability to collect, compile, and analyze information
• Ability to understand and communicate research protocol requirements to others
• Ability to work independently on multiple tasks and manage time effectively
• Software familiarity
• Medical terminology familiarity
• Excellent communication skills
• Strong interpersonal skills