Minnesota Eye Consultants (MEC) is one of the premiere eye care practices in the nation. We believe in One Team, All In. The culture at MEC is one of excellence and teamwork. We are passionate about patient care and dedicated to improving quality of life through life-changing vision procedures and treatments.
MN Eye Consultants is currently hiring for a full-time (1.0 FTE) Clinical Research Coordinator II in our Bloomington clinic.
The Clinical Research Coordinator plays an active role in coordinating assigned clinical research studies from initiation to closure while working with and under the direction of the clinical Principal Investigator and Clinical Research Manager. While the Principal Investigator is ultimately responsible for the clinical trial, this professional is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.
Essential Duties and Responsibilities
- Serves as the primary liaison between clinical study sponsors, patients, and MEC staff regarding study protocol requirements and communicates clinical study information with study participants, providers, clinical study project team, and clinical research manager in an appropriate format.
- Assists with study initiation activities, such as coordinating the delivery of study-related paperwork, equipment, demos, supplies, and participating in study-initiation meetings.
- Attends protocol training sessions and provides training to others as instructed by Principal Investigator and/or Clinical Research Manager.
- Oversees and participates in patient recruitment, screening, and informed consent activities.
- Obtains comprehensive histories and subjective complaints from research participants. Completes patient visits and study-specific procedures in accordance with assigned protocols. Assists other Clinical Research Coordinators with completion of patient visits and study-specific procedures as requested.
- Prepares patient charts for patient visits, ensures complete data collection, and completes data entry in company electronic medical record system and case report forms accordance with clinical study protocols, applicable regulations, and department procedures.
- Responsible for ensuring protocol and regulatory compliance to assigned clinical study protocols.
- Assists with regulatory documentation and filing, report preparation and clinical study communications to external agencies (e.g., sponsor, FDA, IRB) as requested.
- Prepares for and attends all monitor visits. Oversees and participates in resolving action items.
- Assists with internal quality auditing as requested. Identifies quality and department improvement opportunities and communicates suggestions to the Clinical Research Manager.
- Accurately and efficiently obtains and documents the following technical data in compliance with assigned clinical study protocols: refractometry, tonometry (e.g., applanation, tonopen), keratometry, biomicroscopy, A-scans, pachymetry, wavefront testing, photography, corneal topography, visual fields, contrast sensitivity, GDX, tear break-up times, tear volumes, special testing for government agencies, and other tests as needed.
Education and/or Experience
A minimum of one-year experience as an ophthalmic technician. A minimum of one-year prior experience in academic, pharmaceutical, or medical device clinical trials. Working knowledge of federal regulations applicable to clinical trials is preferred. Knowledge of research methodology is highly valued.
Certificates, Licenses, Registrations
Current certification as a COA, COT, or COMT. ACRP (CCRC) or SoCRA (CCRP) preferred.
MN Eye Consultants and Northwest Eye Clinic are now sister companies under Unifeye Vision Partners! To view employment opportunities at all of our locations go to www.unifeyejobs.com
Unifeye Vision Partners provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.