Retina Research Coordinator

Summary

The Research Coordinator will be responsible for safe and effective conduct of clinical trials from start to finish, ensuring visits and procedures are conducted in accordance with the protocol, site standard operating procedures (SOPs), ICH-GCP principles, and regulatory requirements of the IRB and more.

Supervisory Responsibilities

This position does not have supervisory responsibility but will provide guidance to employees and/or assist with orientation and training of new employees of the work group.

Primary Duties and Responsibilities

• Correspond with IRB regarding study start-up, maintenance, study documents, and report safety data as appropriate.
• Review protocol to ensure thorough and accurate data collection and procedures are conducted according to study protocol.
• Conduct chart reviews and interviews to prescreen prospective subjects for studies and schedule screening visits.
• Conduct informed consent discussions in accordance with ICH/GCP principles.
• Maintain source documents and regulatory documentation for clinical trials.
• Carry out study visits and collect study data in accordance with study protocol Maintain regular contact with subjects for thorough safety data collection and ensure study visits are scheduled and carried out in accordance with protocol.
• Present adverse and serious adverse events to Principal Investigator / sponsor / IRB as appropriate.
• Run and review reports in electronic health records (EHR) to gather data about study feasibility and for pre-screening activities.
• Create and maintain standard operating procedures for the site.
• Report research visa expenditures to manager.
• Ensure adequate staff training and maintenance of site equipment.
• Schedule and facilitate monitoring visits.
• Ensure subjects are compensated as outlined in the ICF.
• Clean and maintain equipment and instrumentation in good working condition; perform minor repairs and adjustments as needed.
• Ensure that services and products are appropriate to meeting patient needs and work is performed in an efficient, timely and accurate manner.
• Perform work in compliance with company policy, department procedures and regulatory requirements, including HIPAA and OSHA.

Secondary Functions

• Drawing blood, centrifuging, and freezing blood samples.
• Preparing and shipping study samples.
• Other duties which may be necessary or desirable to serve the patient and support the success of the department or the company overall.

Education and/or Experience; Certificates, Licenses, and Registrations (Minimum Requirements)

• High school diploma or equivalent.
• Certified as an Ophthalmic Assistant (COA) or Ophthalmic Technician (COT) is preferred.
• An equivalent combination of experience, training and certification that would provide the knowledge, skills and abilities required for the successful performance of the essential job duties.

Necessary Knowledge, Skills and Abilities

• Clinical trial experience required.
• Self-directed and ability to multitask required.
• Undergraduate degree preferred.
• Experience with NextGen EHR, Excel, and database experience desired.
• Thorough knowledge of ICH-GCP and awareness of local regulations regarding drug research is required.
• Effective communicator with ability to work well with others required.

Physical Demands / Work Environment

• Majority of work is performed in a general medical office environment. Exposure to moderate levels of noise in a well-lit, well-ventilated, and moderately paced environment; some work is performed in dimmed lighting.
• This position requires manual/finger dexterity as necessary to perform daily job duties.
• Occasionally required to stand and/or walk for extended periods of time.
• Occasionally required to reach with hands and arms; lift, push, pull and/or carry objects up to 20 pounds.

Reasonable Accommodations

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EHN believes that each employee makes a significant contribution to our overall success. That contribution should not be limited by assigned responsibilities. This job description is designed to outline primary functions, qualifications and job scope, but is not intended to limit the employee or EHN to only those job functions identified. EHN expects each employee to offer his or her services wherever and whenever necessary to ensure superior customer service, quality patient care, and the success of our business.