Clinical Research Coordinator (HIRED)
CEENTA has been the region’s premier eye, ear, nose, and throat care provider for adults and pediatric patients for nearly a century. We are the largest multi-specialty practice on the East Coast, with nearly 20 locations throughout North and South Carolina, over 140 providers offering comprehensive adult and pediatric care, and a full list of ancillary departments and services. We are looking for a Clinical Research Coordinator, a healthcare professional responsible for assisting the physician’s investigator with all aspects of conducting a clinical trial by providing medical treatment and medical care services to patients.
The Research Department at Charlotte Eye Ear Nose & Throat Associates, PA, was created in 1992 to coordinate Phase I-IV ophthalmology and otolaryngology clinical trials. For the last 26 years, our patients have been exposed to ground breaking therapies. Our Research department is dedicated to exceeding the objectives and requirements of the drug development process. They strive to provide everyone with excellent clinical trial management and a dedicated, highly-trained and educated staff are the backbone of the quality services they offer.
Duties:
• Assist with the development and execution of clinical research trials
• Identify and recruit research participants through chart review, advertising and other methods
• Coordinate all aspects of the assigned clinical research trials including appointments and follow up sessions.
• Enter data from clinic visits into Site Electronic Medical Records System and Study Electronic Data Capture Systems
• Complete all data entry with accuracy and in a timely fashion as per sponsor guidance
• Receive and maintain Investigational Product per protocol requirements
• Communication and Reporting to Institutional Review Board
• Prepare for and participate in routine sponsor monitoring visits.
• Performs technical requirements of the study’s protocol such as but not limited to; vital signs, ECG, refraction & BCVA, intraocular pressure, phlebotomy, urine/serum pregnancy testing.
• Prepares documentation in the event of a sponsor audit or FDA audit and assist during the audit as needed
• Maintain OSHA standards to ensure sterilized and safe environment.
• Maintain Corporate Compliance standards in regards to patient demographics and medical information
• Maintain certification through continuing education activities
Skills:
• Excellent Communication Skills: effectively by engaging with research subjects, explain what is expected of them, understand their concerns, and consent patients per guidelines.
• Collaborative Team Oriented Approach: when working with physicians, sponsors, research team, clinic staff team and study participants to create collaborative relationships to ensure optimum results.
• Analytical Thinking: Ability to collect data and interpret information and extract the data needed for tasks and programs. Using strong data analysis and attention to detail to collect, process, and assist in the compilation and verification of research data, samples, and/or specimens, following strict protocol and detailed instructions.
• Accountability & Dependability: Takes personal responsibility for the quality and timeliness of work and achieves results with little oversight. Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol with extensive knowledge of ICH-GCP guidelines.
• Self Directed: Ability to work well in fast paced and ever-changing environment to meet the needs of patients and study sponsors.
• Professional Acumen: Demonstrate intention to increase knowledge and skills to benefit the department and Charlotte Eye Ear Nose and Throat. Ability to create a common mindset of learning, growing, and acquiring new skills. Serve as a reference or source of information as needed for the physician regarding billing.
Education/Experience:
Bachelor’s degree (B. A. / B.S.) from four-year College or university; RN; or equivalent combination of education and experience. Prior experience working within Ophthalmology or Otolaryngology a plus but not required.
Benefits:
CEENTA offers a competitive benefits package, including medical insurance coverage on the first day of employment and an employer-matched 401(k). Join our team to provide exceptional patient care and employee customer service.
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