Clinical Research Coordinator

Job Objective: The Research Coordinator will facilitate all facets of GI clinical research studies.

Duties and Responsibilities:•

• Administratively and clinically manage industry sponsored clinical trials
• Assist with protocol design, where requested
• Adhere to Research SOP's, Good Clinical Practices and the study protocols
• Assist in patient recruitment by performing detailed chart reviews and patient interviews
• Discuss study protocols with patients and verify the informed consent documentation
• Review Medical History of patient against Inclusion/Exclusion Criteria of studies
• Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations
• Schedule all patient research visits and procedures consistent with protocol requirements
• Dispense study medication, collect vital signs and perform ECGs
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Ensure the filing and maintenance of all regulatory documents
• Schedule and prepare for monitor visits
• Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy

Qualifications:

• Associates degree in a clinical or scientific related discipline required, Bachelor's degree preferred
• 3+ years previous experience as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials experience preferred
• Computer skills - Microsoft Word, Excel, Power Point, CTMS, EMR
• Previous experience in a role of complex administration or project coordination
• Effective communication skills to include written, verbal and presentation skills
• Strong attention to detail and organizational, analytical, and problem-solving skills
• Periodic local travel to other practice locations on an as-needed basis

Physical Requirements:

• Ability to stand and walk throughout the day
• Prolonged periods of sitting and performing administrative duties including the use of computers
• Ability to bend, twist, stoop, and reach
• Able to lift and carry supplies and equipment as needed (up to 15 pounds)

Physical Demands:

• Applies the principles of body mechanics in lifting or moving charts, boxes, or equipment (occasional)
• Must be able to independently lift 25 pounds (occasional)
• Must be able to sit (frequent), stand (frequent), walk (frequent), stoop (frequent), bend over (frequent), and type on keyboard (frequent).

Work Environment:

• Medical office requiring some contact with adult patients

Equal Opportunity Employer
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