Join to apply for the Research Coordinator RN role at Ohio Gastroenterology Group, Inc.
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Join to apply for the Research Coordinator RN role at Ohio Gastroenterology Group, Inc.
- Administratively and clinically manage industry sponsored clinical trials.
- Adhere to Research SOP's, Good Clinical Practices and Clinical research protocols.
- Assist patient recruitment by performing detailed chart reviews and patient interviews.
- Conduct the Clinical trial informed consent discussion.
- Review of patients' Medical History against Protocol Inclusion/Exclusion Criteria
- Perform blood drawing, processing and shipping blood/urine specimens per study protocol and IATA regulations.
- Schedule all patient research visits and procedures consistent with protocol requirements
- Receive study medication and appropriately document receipt.
- Pull and mix study medications as specified in study protocol.
- Collect vital signs and perform ECGs. Assess patients before Infusion, monitor vital signs during and after infusions, and identify and address any adverse reactions Start IVs and assist with study drug infusion as indicated.
- Assist with routine data verification and quality control, ensuring data integrity and consistency with defined study protocol.
- Ensure 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.
Responsibilities
Duties and Responsibilities
- Administratively and clinically manage industry sponsored clinical trials.
- Adhere to Research SOP's, Good Clinical Practices and Clinical research protocols.
- Assist patient recruitment by performing detailed chart reviews and patient interviews.
- Conduct the Clinical trial informed consent discussion.
- Review of patients' Medical History against Protocol Inclusion/Exclusion Criteria
- Perform blood drawing, processing and shipping blood/urine specimens per study protocol and IATA regulations.
- Schedule all patient research visits and procedures consistent with protocol requirements
- Receive study medication and appropriately document receipt.
- Pull and mix study medications as specified in study protocol.
- Collect vital signs and perform ECGs. Assess patients before Infusion, monitor vital signs during and after infusions, and identify and address any adverse reactions Start IVs and assist with study drug infusion as indicated.
- Assist with routine data verification and quality control, ensuring data integrity and consistency with defined study protocol.
- Ensure 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.
- Current OBN RN license
- 3+ years previous experience as a Clinical research coordinator or Clinical trial monitor for pharmaceutical phase II or III trials, GI trials preferred.
- BLS/ACLS current
- Experience with infusion pumps
- Excellent IV skills
- Excellent assessment skills for patients undergoing study infusion drugs.
- 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 diligence and organizational, analytical, and critical thinking 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 fifteen pounds)
Physical Demands
- Apply the principles of body mechanics in lifting or moving charts, boxes, or equipment (occasional)
- Must be able to independently lift twenty-five 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 offices require contact with adult patients.
- Positive Teamwork skills a must
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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Research, Analyst, and Information TechnologyIndustries
Medical Practices
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