Clinical Research Coordinator

POSITION SUMMARY:

The Clinical Research Coordinator assists investigators by performing all duties aligned with the study and acts as a liaison with the patient community, study sponsor and CRO. Advance your career in retina research while working one on one with renowned Retina Specialists. The Clinical Research Site we partner with for this role is on the forefront of upcoming medication research ranging from Phase I to IV trials.

SKILLS AND ABILITIES:

• Self-driven.

• Willingness to adapt to changes and learn new medical diagnostic modalities.

• Maintenance of professional relationships.

• Effective communication within the scope of responsibility.

• Excellent organization and prioritization skills.

• Creating an environment of exceptional customer service.

• Proficient with technology including Microsoft Office Suite.

• Ability to multi-task in a fast-paced environment.

• Use critical thinking skills to follow best practice.

REPORTING RELATIONSHIPS:

Director of Clinical Research

PRINCIPLE DUTIES & RESPONSIBILITIES:

• Support company's core values, mission, goals, and objectives.

• The position supports, facilitates, and coordinates daily clinical trial activities and plays a critical role in the conduct of Retina Research.

• Ability to perform ophthalmic intake (obtain medical history/medications, check vision, intraocular pressure via tonopen, instill ophthalmic drops) and scribe.

• Job requires interaction with patients, data entry, scheduling, communication with outside study monitors, specimen processing, and query resolution.

• Required to be articulate, personable, reliable, computer savvy, and intellectually agile.

• Maintain IATA and GCP certificates.

• Follow ALCOA guidelines.

• Always maintain patient confidentiality under HIPAA. Actively applies knowledge of FDA and ICH Good Clinical Practice guidelines throughout study performance to ensure compliance with these standards.

• Assists investigators in preparing documents, performing medical diagnostic assessments (MAIA, HVF, specular microscopy, urine/blood lab processing, ECG, etc.), and treatment preparation in accordance with study protocols.

• Able to follow study manuals regarding storage and maintenance of Investigational Product.

• In charge of scheduling participant visits, data collection, data management, assisting with clinical assessments, regulatory documentation, and following study protocols.

• Ability to maintain masking in double-masked protocols.

• Aids with recruitment of participants into studies and reviews medical history along with protocol specific inclusion/exclusion criteria.

• Assures timely completion of study procedures and data entry into electronic data capture systems.

• Maintains adequate inventory of study supplies.

• Acts as liaison between patient and investigators to ensure continued patient participation in the study.

• Ability to create source documents per the protocol Schedule of Assessments.

• Enter each participant in the appropriate billing system to ensure study procedures are captured and are associated with the correct funding source.

• Creates and submits correspondence, reports, other documents and related materials to study sponsors and CROs.

• Works with the PI and study team to manage the day-to-day activities of the study including problem solving, communication, and protocol management.

• Working knowledge of anatomy and physiology of the eye. Understanding of the theory and the workings behind pertinent testing. Knowledge of ocular diseases. Knowledge of systemic diseases and their impact on the eyes. Able to use and understand medical jargon.

PHYSICAL REQUIREMENTS:

• Adequate corrected hearing and visual acuity to perform the essential functions of the job.

• Clearly speak English and articulate and present information to employees and the public.

• Lift up to 50 pounds.

• Stand and walk for an entire work shift with minimal breaks.

• Move quickly for an entire shift if needed.

JOB LOCATION/WORKING CONDITIONS:

• Work from one main office and four surgical operating facilities.

• Private practice environment with frequent lifting and transporting supplies downstairs to the basement lab.

• Designated office space.

• Able to travel domestically to attend sponsor Investigator Meetings.

• Flexible working hours involving early OR start times and meetings with outside personnel.

QUALIFICATIONS REQUIRED:

• Previous experience in Ophthalmology and/or a research environment preferred.

• Equivalent of high school diploma with some College coursework preferred.

• Working knowledge of Microsoft Office.

• Experience with medical EMR systems.

• Ability to perform ophthalmic technician assessments and scribe.