Dr. Woreta and Dr. Johnson are seeking a highly motivated individual for the position of a CO Sr. Research Program Coordinator II who will be responsible for managing several clinical research studies with partnering principal investigators and co-investigators. The individual will work collaboratively within a research team, under minimal to no supervision, to achieve clinical research goals and outcomes. The role involves participation in the design of clinical studies, data collection, data analysis, and scientific writing as well as the development of specific research projects, with the assistance of Principal Investigators. For Dr. Woreta, the person will specifically be involved in research projects related to medical education, disparities in ophthalmic health and ophthalmic trauma. For Dr. Johnson, the projects will focus on glaucoma such as identification of biomarkers of glaucoma, biomechanical changes in optic nerve head with intraocular pressure changes, use of home tonometry device in patients with glaucoma and patients with concurrent glaucoma and cataract surgery. The individual will also be responsible for managing a team of medical students, coordinators and research fellows and provide training to other members who may be assigned to the team on a regular or temporary basis. Preferred candidates should demonstrate excellent communication and organizational skills and the ability to work well independently.

Specific Duties & Responsibilities

• Work independently and under the direction of the supervisor to ensure successful completion of each clinical research study.
• Work with study Principal Investigators (PI) and serve as a liaison with collaborators to coordinate, supervise the day-to-day clinical research operations and data collection.
• Identify, recruit, enroll and follow-up with patients in Ophthalmology clinical trials
• Assist PI with informed consent and implements research protocols through recruiting and enrolling eligible patients into studies.
• Coordinate patient care and visits based on study protocols.
• Monitor the clinical course of patients enrolled in clinical trials and ensure that research protocols are executed appropriately.
• Monitor study participants for adverse events.
• Responsible for training study participants in the use of the iCare HOME handheld tonometer and measuring corneal-compensated intraocular pressure and corneal hysteresis during study clinic visits.
• Guide patients through study activities and identify and resolve potential compliance issues.
• Act as the point of contact for study participants, offering a responsive and supportive channel for addressing inquiries, concerns, and device-related issues.
• Travel to Wilmer's satellite locations to enroll new study participants and ensure standardized protocols across different sites.
• Collect, process, and store biofluid samples to be analyzed using the SomaScan platform at or on behalf of FireCyte Therapeutics.

Assist the PI in overseeing and maintaining institutional regulatory compliance

• Assist in preparing the IRB initial application, annual IRB continuing reviews, changes in research, protocol amendments, annual reports and events reports according to IRB requirements.
• Communicate all necessary information to sponsors and IRB.
• Responsible for assisting the PI with drafting data sharing agreements for collaborative projects with other investigators outside of JHU.
• Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status.

Collect and organize research data by extracting clinical information from a variety of sources.

• Review medical charts in Epic and extract data for chart review.
• Review of ophthalmic imaging and testing, including visual field testing and optical coherence tomography of the retinal nerve fiber layer, to extract relevant data for input into databases.
• Enter data, control data quality, and maintain research & data integrity.
• Maintain a comprehensive repository of documents and records related to study participants and research endeavors.
• Ensure accuracy and timeliness of data collection and perform quality checks on data entry.
• Responsible for communicating, sending data, receiving data, and analyzing data in conjunction with collaborators.
• Exercise oversight over the entire spectrum of data collection activities, including record keeping of all study related information and database entry.
• Organize data for input into statistical software programs.

Assist in Scientific writing

• Draft and edit manuscripts.
• Actively participate in study meetings and generate ideas for analyses and publication of study data.
• Draft manuscripts describing the results of clinical research studies for publication.
• Present the results of clinical research studies at research conferences.
• Assist the PI with drafting of grant proposals to fund clinical research projects and in drafting research protocols.
• Meet regularly with Principal Investigators to review data accuracy and overall study progress and status.
• Mentor and oversee team members including research students and other fellows who may also be participating in clinical research studies.

• Bachelor's Degree in related discipline. Related Master's preferred.
• Five years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Clinical trial experience a strong additional plus.

Classified Title: Sr. Research Program Coordinator II 
Job Posting Title (Working Title): CO Sr. Research Program Coordinator II   
Role/Level/Range: ACRP/04/MC  
Starting Salary Range: $48,000 - $84,100 Annually (Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday-Friday, 8:30 am - 5:00 pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Oph Glaucoma 
Personnel area: School of Medicine