Job Title

DescriptionColorado Retina has an exciting opportunity for a Full-Time Research Coordinator - On-Call not required!Colorado Retina Associates is the premier provider of vitreoretinal clinical care and surgery, recognized for our expertise, innovation, and compassionate care approach. As the largest and most experienced ophthalmology practice in Colorado, we excel in managing highly complex ocular cases through collaborative teamwork. Since our inception in 2006, our team has been committed to fighting blindness, participating in more than 90 national clinical trials to bring our patients the newest, most advanced treatment options. To continually enhance our services, we invest significantly in our staff, research, facilities, and cutting-edge technology.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 OF RESPONSIBILITIES: The research coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.ROLES and RESPONSIBILITIES:Role and Responsibilities: Facilitates and coordinates daily clinical trial activities, playing a critical role in study conduct. Administers sponsor-required questionnaires (e.g., VFQ) Works with team members responsible for ordering study supplies to ensure adequate inventory. Creates, manages, and maintains source documents for each trial. Attends teleconferences and Investigator Meetings as requested by the research director. Reviews and comprehends all study protocols, including proceedings, timelines, inclusion/exclusion criteria, confidentiality, and privacy protections. Collaborates with the study and clinical team to recruit eligible candidates and screens subjects for eligibility. Efficiently completes all delegated study tasks (e.g., scribing, questionnaires, IOP, etc.) Collects updated medical history, adverse events, and serious adverse events for reporting to the sponsor and IRB within the required timeframe. Conducts/involves in the informed consent process/discussion with research participants. Acts as a secondary reviewer to ensure accurate implementation of amended consent forms and procedures. Collects protocol-required data and enters information into the electronic data capture (EDC) system within specified timeframes. Oversees data accuracy and resolves queries issued within the required timeframe. Collects and reports ALL Adverse Events and Serious Adverse Events. Ensures acknowledgment and review of ALL SUSAR/Safety Reports. Coordinates monitor site visits, assisting with preparation of documentation. Works with the monitor to make corrections as needed to meet requirements and deadlines. Manages and maintains all regulatory information about the study, including protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, and reporting instructions. Ensure protocol compliance during procedures, assist physicians with IP administration, and follow randomization procedures accurately. Order, track, and maintain detailed records of clinical supplies related to protocols. Ensure proper storage temperature and maintain storage logs as necessary. Document and record all shipments, returns, and destruction per sponsor requirements. Work closely with study team to ensure proper IP transport, administration, missing, and administration. Obtain and maintain any applicable additional/required sponsor training and/or certifications. Coordinates monitor site visits and assists with preparation of site visit documentation. Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor. Understand and maintain and working knowledge of protocol to ensure protocol procedures and visits are completed and in compliance with sponsor requirements.EDUCATION and EXPERIENCE:Level IEducation:College degree preferred or significant relevant experienceOphthalmic experience preferredExperience / Knowledge / Skills: 1-3 years prior research experience (i.e., as a research assistant)Effective oral and written communicationDelivers safe and appropriate care to patients in addition to the requirements outlined by study protocolsCertifications / Training: ICH GCP Training / CertificateIATA Certification 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 throughCOMPENSATION:Base Salary: $50,369.73 - $80,591.56 (based on education and experience, Level I)We do not take evening, weekend, or holiday on-call!Our benefits include Competitive salarySafe harbor/profit sharing planfull medical, dental, and vision insurancePet insuranceLegal, life, accident, disability, and hospitalization insurance