Research Assistant

Job highlights
Identified by Google from the original job post
Qualifications
High School diploma or the equivalent, with significant relevant experience
Effective oral and written communication
Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols
Benefits
Competitive salary
Safe harbor/profit sharing plan
full medical, dental, and vision insurance
Pet insurance
Legal, life, accident, disability, and hospitalization insurance
Salary Range: $20.87 - $33.3+ per hour
Responsibilities
Responsible for support of the research department and clinical research coordinators
This position requires excellent organization skills and attention to detail
The clinical research assistant will work closely with the research coordinators to ensure procedures are completed per protocol requirements
Any data collected and documented will be done according to ICH/GCP guidelines and strict protocol adherence is maintained
Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines
Prepare visit-specific documentation and charts for Clinical Research Coordinator
Observe Coordinator in patient care and management
Assist Coordinator in monitoring subject flow and assist in subject care and management
Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
Transcribe subject study information from source documents to the Electronic Case Report Forms
Administer all mandatory questionnaires to study subjects
Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol
Promptly request all necessary medical records for Serious Adverse Event Reporting
Process and ship laboratory biological samples for analysis
Perform intraocular pressure checks after injections
Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)
Inform subjects and obtain written re-consents in regard to ICFs
Perform other duties as assigned
Obtain any applicable additional/required sponsor training and/or certifications
Assist Coordinator in CTMS management
Review and resolve data management queries as needed
Inform subjects and obtain written consent in regard to ICFs (on selected studies)
Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol
Submit images to CRCs as needed
All duties included in RA Level II in addition to:
Assist and perform unmasked duties for ISTs and Phase 1 studies, including maintaining IP and shipping logs
Perform Serious Adverse Event reporting, initial & follow up reporting, including the prompt request of all necessary medical records, review of medical records and updated reporting
Train and understand all aspects of regulatory compliance
Assist Coordinator in regulatory management, including training and monitoring visits Transcribe and perform query resolution regarding subject study information from source documents to the Electronic Case Report Form
Job description
Who We Are

Colorado Retina is a physician, sub-specialty eye care practice providing medical and surgical care of vitreoretinal eye disease. We provide comprehensive treatment for age-related macular degeneration (AMD), diabetic retinopathy, retinal vascular disease, retinal detachments, ocular tumors, uveitis/inflammatory eye disease, inherited retinal degenerations and numerous other vitreoretinal conditions.

We are proud to be the largest retina practice in the Rocky Mountain region with the ability to collaborate as a team for highly complex cases. We provide several service locations in the Denver Metro area: East Denver (Central Park), Lakewood, Lafayette, and Parker. Colorado Retina has an exciting career opportunity for a Clinical Research Assistant.

Colorado Retina Associates is complying with the Covid-1+ Vaccine Mandate. Colorado Retina requires employees to be vaccinated as a condition of employment, subject to accommodation. All candidates, upon hire, will be required to provide proof of vaccination or have a valid accommodation.

Summary:

Responsible for support of the research department and clinical research coordinators. This position requires excellent organization skills and attention to detail. The clinical research assistant will work closely with the research coordinators to ensure procedures are completed per protocol requirements. Any data collected and documented will be done according to ICH/GCP guidelines and strict protocol adherence is maintained.

Job duties/responsibilities:

Level I
• Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.
• Prepare visit-specific documentation and charts for Clinical Research Coordinator
• Observe Coordinator in patient care and management
• Assist Coordinator in monitoring subject flow and assist in subject care and management
• Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
• Transcribe subject study information from source documents to the Electronic Case Report Forms
• Administer all mandatory questionnaires to study subjects
• Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol
• Promptly request all necessary medical records for Serious Adverse Event Reporting
• Process and ship laboratory biological samples for analysis
• Perform intraocular pressure checks after injections
• Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)
• Inform subjects and obtain written re-consents in regard to ICFs
• Perform other duties as assigned
• Obtain any applicable additional/required sponsor training and/or certifications

Level II

All duties included in RA Level I in addition to:
• Assist Coordinator in CTMS management
• Review and resolve data management queries as needed
• Inform subjects and obtain written consent in regard to ICFs (on selected studies)
• Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol
• Submit images to CRCs as needed

Level III

All duties included in RA Level II in addition to:
• Assist and perform unmasked duties for ISTs and Phase 1 studies, including maintaining IP and shipping logs
• Perform Serious Adverse Event reporting, initial & follow up reporting, including the prompt request of all necessary medical records, review of medical records and updated reporting
• Train and understand all aspects of regulatory compliance
• Assist Coordinator in regulatory management, including training and monitoring visits Transcribe and perform query resolution regarding subject study information from source documents to the Electronic Case Report Form

Education and Experience:

Level I

Education:
• High School diploma or the equivalent, with significant relevant experience
• College degree preferred
• Ophthalmic experience preferred
• Effective oral and written communication
• Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols

Preferred Skills/Experience:
• Efficiently and accurately interviews patients and documents histories
• Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
• Accurately performs labs, ECG, tonometry, pupil exam, data entry, and other specified duties
• Possesses excellent organizational skills to independently manage workflow
• Pays meticulous attention to detail
• Takes initiative and possesses the insight and energy to prioritize quickly
• Demonstrates high-level critical thinking skills
• Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
• Demonstrates excellence in communication skills, both personal and written, as well as organizational and time-management skills
• Demonstrates ability to effectively convey ideas and information and able to creatively generate ideas with excellent follow through

Our benefits include
• Competitive salary
• Safe harbor/profit sharing plan
• full medical, dental, and vision insurance
• Pet insurance
• Legal, life, accident, disability, and hospitalization insurance

Job Status:
• Full time

Salary Range: $20.87 - $33.3+ per hour

Colorado Retina is proud to be an equal-opportunity employer and is committed to providing a workplace free from harassment or discrimination. All employment decisions are made without regard to race, color, age, gender, gender identification, ****** orientation, religion, marital status, sex, pregnancy or conditions related to pregnancy, national origin/ancestry, citizenship, disability, military status, genetic information, or any other basis prohibited by law. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, training, and career development programs.