Research Coordinator

Job Description

Over the years, Ophthalmology LTD's name has become associated with the highest quality of comprehensive medical and surgical eye care. Ophthalmology LTD delivers treatments for cataracts, glaucoma, and diabetic eye disease, as well as cornea transplants, oculoplastic surgery, retina surgery, vitreoretinal surgery, and pediatric eye care in Sioux Falls.

Our busy ophthalmic practice seeks a dynamic individual with strong organizational skills to operate as a full-time Research Coordinator for our practice. The selected candidate will be extremely valuable in managing and ensuring the well-being of ophthalmic patients enrolled in the clinical trials our office engages in. Coordinates research patient visits according to the ICH-CGP guidelines, the IRB-approved study protocol, and the manual of procedures. We desire a meticulous attention to detail. Works closely with the research team to provide exceptional care to study patients and ensure that studies are conducted accurately and ethically. Responsibilities include completion of Case Report Forms and of all AE/SAE forms, and all aspects of patient enrollment and follow-up visits. The successful candidate will possess a commitment to the project, a positive attitude; must have a strong attention to detail and be able to adapt to a flexible schedule. Prior experience as a CRC preferred but not required.

1. Responsibilities:
   1. Assists with study initiation activities, such as coordinating the delivery of study related paperwork, equipment, demos, supplies and participating in study-initiation meetings.
   2. Works with Finance Manager to establish budgets, track invoices, approve vendor activity and assists in budget reconciliation.
   3. Overseeing and participating in patient recruitment, screening, scheduling and informed consent activities.
   4. Preparing patient charts for patient visits, ensuring complete data collections, and assisting clinical research technicians with case report form completion as requested.
   5. Assisting in monitoring visits with sponsor staff (queries, source document reconciliation, preparing regulatory documents, answering questions).
   6. Ensuring protocol and regulatory compliance as established by clinical study.
   7. Appropriately and accurately communicates clinical study information with sponsors, primary investigator, physicians, research teams, and study participants.
   8. Manages and maintains all regulatory information about the study, including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor.
   9. Maintaining accurate clinical study electronic and hard copy documentation in accordance with clinical study protocols, applicable regulations, and departmental procedures.
   10. Tracking study supply inventory and re-ordering as necessary.
   11. Collect, process, package and ship research specimens according to DOT and IATA regulations.
   12. Extract data from source documents for research studies as directed. Collect data and complete case report forms.
   13. Retains records/archives documents after study close out.
   14. Collects and reports all Adverse Events. Collects and reports all Serious Adverse Events within 24 hours of notification of event.
2. Other Duties:
3. Assist with other research and clinical duties as assigned.
4. Answer phone calls and direct calls to the appropriate areas.
5. Tests ocular functions, including visual acuity, muscle balance, and intraocular tension. Performs additional testing based on research requirements.

Qualifications:

• Education and Training: High School Diploma or equivalent. A college degree or significant relevant experience is preferred. Certification is encouraged (i.e., CCRC-Certified Clinical Research Coordinator, COA-Certified Ophthalmic Assistant, COT-Certified Ophthalmic Technician).
• Prior Work Experience: Ophthalmic Technician or prior research experience preferred; must have a minimum of 2 years medical hospital/clinic experience or equivalent with knowledge of medical terminology, procedure codes and diagnosis codes as it applies to recruiting subjects for research.
  
• Special Skills: Effective verbal and written communication skills. Excellent organizational skills, multi-task, attention to detail and logical thinking. Delivers safe and appropriate care to subjects in addition to the requirements outlined by study protocols. Able to creatively generate ideas with excellent follow-through. Ability to learn quickly, work as a team player and complete tasks with minimal supervision.

Functional Requirements:

• Physical Demands: Work requires prolonged walking, sitting, bending, stooping and stretching. Requires manual dexterity sufficient to operate a keyboard, calculator, telephone, copier, and other office equipment as necessary. Vision must be correctable to complete required tasks and hearing must be within normal range.
  
• Mental Demands: Requires close mental attention and knowledge of medical terminology. Skills in communication, grammar, and spelling.
  
• Confidential Data: Must comply with Ophthalmology Ltd. policy on confidentiality of patient information, data, and records.

Infection Control and Safety Requirements:

• Use universal precautions and protective measures as outlined in the Ophthalmology Ltd. Exposure Control Plan and other pertinent documents to protect self and others from the transmission of blood borne and communicable diseases.
  
• Learn and comply with all practice safety rules; must use appropriate safety equipment and devices at all times; must immediately report all unsafe conditions to the manager; must be familiar with all safety features of equipment, devices of materials utilized in performing job duties and must verify with manager before starting a task if there is any question as to proper or safe procedures.

All job responsibilities are subject to change as deemed necessary by direct report. The essential functions of this position have been determined by the effective date of this position description. This position description may be supplemented and/or modified as changes to the position occur. Associates are required to comply with policies and procedures of Ophthalmology Ltd. as well as to perform other duties and responsibilities as written.

Ophthalmology Ltd. offers a strong compensation and benefit package to all employees.

We are an EO employer - Minority/Female/Veteran/Disability