Clinical Research Coordinator

Essential job functions:
• 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

Core competencies:
• Reliability and Dependability: Dependability and trustworthiness. Maintains acceptable attendance and punctuality.
• 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.

Supervision:
• Clinical Research Coordinator reports to the Director of the Clinical Research Department.
• This position has no supervisory responsibilities.

Work environment:
The Clinical Research Coordinator functions in a busy eye, ear, nose and throat practice. This role may be exposed to contagious or infectious diseases, and therefore, may be required to wear personal protective equipment at times. This position routinely uses standard medical office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit, talk, or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms to assist patients and/or clinic staff.

Position type and expected hours of work:
This is a Clinical Research Coordinator position with hours dependent upon clinic needs, however it is typically 8am-5pm Mondays-Fridays.

Travel:
• Travel could be necessary for content related training. Position would often travel between various locations to meet clinical needs.

Education and experience:
• Bachelor’s degree (B. A. / B.S.) from four-year College or university; RN; or equivalent combination of education and experience required.
• Prior experience working within Ophthalmology or Otolaryngology a plus but not required.

Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. In addition to those essential job functions identified above in Section II, individuals in this position are also responsible for performing other duties or tasks that may be assigned. CEENTA retains the discretion to add to or change the essential job functions of this position at any time without notice.