Clinical Research Department: Provides patients with new therapies that are not yet available commercially. We also can provide patients with approved therapies at no cost or reduced costs to them. These medications are given alone or in conjunction with another new therapy.
Our Goal: Patients that are referred to our department are offered these therapies as an alternative to standard of care. Some trials are offered when there are no standard of care options for patients. Patients that are entered into clinical trials are being asked to adhere to a more complex schedule than our standard of care patients. Because of this, we go out of our way to accommodate them as much as possible while adhering to multiple protocol requirements and schedules.
Duties:

• Protocol Review - Each new protocol must be read thoroughly to ensure understanding of the contents. This information is explained to patients so they can make an informed decision on study participation. Typically sponsors of the trials conduct meetings that the coordinator is expected to attend. It may be conducted in the form of a teleconference or the coordinator may be expected to travel to a meeting. At these meetings the training for the study is conducted for a better understanding of the protocol and procedures related to the study.
• Scheduling - Research appointments can be complex and requires attention to detail. Each protocol has target dates and windows according to the visit schedule for that study. Patients have to be scheduled in particular time frames with careful consideration of patient availability, multiple testing and doctors schedules.
• Patient visits - During patient visits coordinators follow patients through their visit to ensure all data is captured that is required for the study. Patient visits can include refraction, vitals, ECG, labs, photography, exams by physician and treatments. During these visits we also collect updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB. These reports typically have to be reported within 24-48 hrs depending on protocol requirements.
• Data Entry - During patient visits there are multiple pages of source documents that have to be completed per protocol. After patient visits, coordinators will transfer that information to either a paper case report form or an electronic case report form that will be monitored by the sponsor appointed party. Data entry usually has to be entered within a certain number of days after the patient visit.
• Certifications/Training - Clinical Research Associates are required to obtain certifications for required procedures in multiple studies. Each study may require different certifications as determined by the protocol. Certifications/training are typically acquired for following testing but not limited to:
• Refraction/VA testing
• Photography including: OCT/Color photography/Fluorescein angiography/ICG angiography
• Human Protection
• ICH Guidelines
• IATA for handling/shipping for transport of dangerous goods
• ECG
• Data entry
• Handling and processing lab samples.
• Monitoring Visits - Throughout each study there will visits by the appointed monitor to review all data and regulator requirements related to the study to ensure compliance. Study coordinators work with the monitor to make any corrections needed to meet requirements and deadlines as needed.
• Regulatory - Regulatory information includes all of the information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CV’s, training documentation, instructions on reporting requirements for the IRB and the sponsor. The study coordinator ensures these binders are kept up to date with all required information.
• Standard Operating Procedures - Clinical research has an SOP binder that includes instructions on chart documentation, informed consent, on site drug destruction, destruction of ancillary supplies and other procedures that the coordinator must be familiar.
• Financial Reporting - All studies having different financial reporting information. Study coordinators must be familiar with and report which items are study related and which items should be billed to the patients’ insurance company including treatments administered but not paid for or supplied by the study. Clinical research routers and clinic encounters must be completed daily to reflect these items.
• Additional Item of Note - Each associate will have different amounts of responsibility for different areas of research. Some of what determines their responsibility is based on what they are allowed to do according to masking requirements for each study. Associates must be goal oriented, able to multi-task and be able to meet deadlines as directed by the sponsor.

Minimum Demonstrated Skills/Qualifications:
Efficiently and accurately interviews patients and documents histories
Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
Accurately performs: labs, EKG, tonometry, pupil exams, data entry, and other specified duties
Multi-tasking and listening skills
Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
Demonstrated excellence in communication skills
Organizational and time management skills
Demonstrate ability to effectively convey ideas and information
Creative idea-generating individual with excellent follow through abilities
Minimum Education Requirements:
High School diploma or the equivalent
Minimum Background Requirements:
Previous experience or training (up to 3 years) in this or similar position
Physical Demands (to be meet with or without reasonable accommodation):
Must be able to stand for long periods of time
Must be able to write
Must be able to hold arms at shoulder height
Must be able to communicate via telephone
Must have manual dexterity to work with ophthalmic equipment