Research Assistant at Colorado Retina Associates in Denver, Colorado

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-19 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 CoordinatorObserve Coordinator in patient care and managementAssist Coordinator in monitoring subject flow and assist in subject care and managementObserve, 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 FormsAdminister all mandatory questionnaires to study subjectsSet up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocolPromptly request all necessary medical records for Serious Adverse Event ReportingProcess and ship laboratory biological samples for analysisPerform intraocular pressure checks after injectionsPerform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)Inform subjects and obtain written re-consents in regard to ICFsPerform other duties as assignedObtain 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 managementReview and resolve data management queries as neededInform 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 protocolSubmit 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 logsPerform Serious Adverse Event reporting, initial & follow up reporting, including the prompt request of all necessary medical records, review of medical records and updated reportingTrain and understand all aspects of regulatory complianceAssist 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 experienceCollege degree preferredOphthalmic experience preferredEffective oral and written communicationDelivers 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 historiesDemonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medicationsAccurately performs labs, ECG, tonometry, pupil exam, data entry, and other specified dutiesPossesses excellent organizational skills to independently manage workflowPays meticulous attention to detailTakes initiative and possesses the insight and energy to prioritize quicklyDemonstrates high-level critical thinking skillsCooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional mannerDemonstrates excellence in communication skills, both personal and written, as well as organizational and time-management skillsDemonstrates ability to effectively convey ideas and information and able to creatively generate ideas with excellent follow through
Our benefits include
Competitive salarySafe harbor/profit sharing planfull medical, dental, and vision insurancePet insuranceLegal, life, accident, disability, and hospitalization insurance
Job Status:
Full time
Salary Range: $20.87 - $33.39 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, sexual 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.