IP Coordinator - Unmasked Research

Colorado Retina Associates is looking for a IP Coordinator Unmasked! Colorado Retina Associates is the premier retina practice of the Rocky Mountain region. Come join a team that strives to provide advanced care and cutting-edge therapies for our patients. Just as we aim to have top notch patient care, we aim to take great care of our team members by providing competitive salary & benefits, continuing education and advancement programs, and an opportunity to work with the top-ranked retina specialists in the US with state-of-the-art equipment and retina treatment methods. JOB TYPE/COMPENSATION: Full TimeClinical ResearchBase Wage: $50, 369.73 - $80, 591.56 (based on education and experience) Position Summary: The unmasked research coordinator is primarily responsible for coordinating research patient treatment visits according to both the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the Institutional Review Board (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. Role and Responsibilities: IP Coordinator Level I: Conduct unmasked monitoring visits Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study for unmasked purposes Works with team member responsible for ordering study or ancillary supplies to ensure adequate inventory is on hand Ensures study staff is properly trained on study-related information (i.e. protocol, Informed Consent Form (ICF), manuals, etc.), aseptic and sterile field technique, and ensures the training is documented Reviews and comprehends all study protocols and procedure/pharmacy manuals Efficiently completes all study tasks delegated to them (i.e. scribing, Intraocular pressure [IOP], etc.) Manage of unmasked RAs (if applicable) Collects updated adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframe per the protocol and in accordance with RCA Standard Operating Procedure (SOP) Answer any unmasked study-related questions from subject Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract (if applicable)15AUG2025 3 Oversees data and ensures that it is being entered correctly and resolves any queries issued within required timeframe (if applicable) Collects and reports ALL Adverse Events in a masked fashion Collects and reports ALL Serious Adverse Events in a masked fashion Subject safety check-in calls Works with the monitor to make any corrections needed to meet requirements and deadlines as needed Obtain any applicable additional/required sponsor training and/or certifications Education and Experience: High School Diploma / GEDCollege degree or 2-3 years ophthalmic experience Preferred Skills/Experience: Unmasked Research Assistant (RA) III = 1-3 years or o Prior annual review or promotion assessment exceeds expectations and shows high proficiency in the job requirements o Effective oral and written communication o Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols o Conducts safe and appropriate aseptic and sterile field techniques Certificates & Licenses: ICH GCP Training / CertificateCCRC/CCRA/CPI preferred but not required Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.Ability to maintain regular, punctual attendance consistent with the state and local standards.Ability to occasionally stand; walk; sit; use hands/fingers to handle, or feel, and reach with hands and arms.Ability to occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.Must be able to talk, listen and speak clearly in person and on the telephone.Work Environment: Work is occasionally performed in emergency and stressful situations. The noise level in the work environment is usually quiet in office settings and moderate in other situations. While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job. The Americans with Disabilities Act requires that reasonable accommodation be provided to qualified individuals to help them to perform the required duties and tasks of the position. Please inform us at the time you apply for a position if you will need any specific accommodations. Colorado Retinawill provide the following compensation: Base Salary: $50, 369.73 - $80, 591.56 (based on education and experience)Medical, Dental, and Vision InsuranceRetirement Safe Harbor/Profit Sharing PlanLegal, Life, Accident, Disability, and Hospitalization InsurancePet Insurance and other incentives