Research Coordinator
2 weeks ago
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
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