Clinical Research Coordinator

Minnesota Eye Consultants (MEC) provides eye care and vision treatments. The Clinical Research Coordinator coordinates assigned clinical research studies from initiation to closure, facilitating daily trial activities under the direction of the Principal Investigator and Clinical Research Manager.

Responsibilities

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

Serves as the primary patient contact in areas such as counseling the patient on visit requirements, study purpose, and study costs, etc. and provides high-quality patient care by promptly addressing patient information needs

Facilitates patient visit scheduling and tracking in accordance with the study protocol

Responsible for ensuring protocol and regulatory compliance to assigned clinical study protocols

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 (e.g., meeting minutes, status reports, telephone calls, e-mails, memos, and letters)

Maintains test article accountability per sponsor and internal standards

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

Represents clinical research department on internal project teams as requested

Complies with OSHA infection control and blood-borne pathogen exposure control procedures

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

Other duties as assigned

Preferred

Working knowledge of federal regulations applicable to clinical trials is preferred

Knowledge of research methodology is highly valued

Federal Clinical Trial Regulations

Research Methodology

Benefits

Health Insurance (medical, dental, vision)

Paid Time Off (PTO)

Holiday Pay

401K Retirement Savings Plan

Accident Insurance

Hospital Indemnity Insurance

Critical Illness Insurance

Life/AD&D Insurance

Disability Insurance

Commuter benefits

Dependent Care benefits

Adoption & Surrogate benefits

Pet Insurance

Employee Assistance Program

Employee Discounts

Company

Ophthalmology clinic specializing in LASIK and cataract surgery

Bloomington, Minnesota, USA

https://www.mneye.com/

Founded in 1989

201-500 employees

Qualifications

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

A minimum of one-year prior experience in academic, pharmaceutical, or medical device clinical trials.

Required skills

Represents the skills you have, click on the tags, Federal Clinical Trial Regulations, Research Methodology

Preferred skills

Knowledge of research methodology is highly valued

Experience

1+ years