Clinical Research Coordinator
TL;DR
As a Clinical Research Coordinator, you have mastered the art of multitasking, prioritizing, and efficiency. Your acute attention to detail has all your peers asking you to proofread their work (which you love doing!). You thoroughly enjoy dissecting and internalizing large amounts of information. When faced with a challenge, you pull from your experience, grab your tools, and execute a plan. You consider yourself a rule follower, but able to pivot if the situation calls for it. When given an assignment, you are the project manager, set your own deadlines, AND crush them. Patient care and excellent bedside manner is a top priority for you. Your hobbies include reading, checking things off your to-do list, and creative projects. You're not afraid to think outside the box or work outside of your comfort zone. As a Clinical Research Coordinator, you see yourself further developing your skills to grow your career in a patient-facing setting because you care about the community in which you serve. You have a minimum of 1 year previous clinical research experience. Bachelor's degree required. What you will own & improve- Coordinate patient visits. You will be responsible for independently conducting complex interventional & therapeutic protocols in compliance with FDA regulations and ICH-GCP guidelines. You may coordinate at each of our 5+ offices we work in throughout the Phoenix valley.
- Patient acquisition. You will be responsible for meeting enrollment goals for studies in which you are assigned as lead by means of chart review, lunch-and-learns, and other community outreach activities.
- Cultivate positive relationships. Develop and maintain strong connections with all of our customers (Sponsor/CRO & Physician Specialists).
- Adhere to strict safety parameters. You will be responsible for identifying, documenting, and reporting adverse events, protocol deviations, and other unanticipated problems. Duties may include liaising with laboratories regarding findings. All the while consulting with the Principal Investigator and patient in order to assess patient eligibility into the trial and throughout their participation.
- Drug records and dispensing. You are responsible for maintaining detailed records regarding drug receipt, dispensing, and maintenance. This includes patient education and monitoring adherence to study rules
- Assessments and exams. You are responsible for obtaining training, certification, and maintaining credentials to perform various tasks as defined by study protocols.
- Process important study information. You will be responsible for reading and internalizing incoming information from study bulletins, newsletters, and memos. This information may require you to update documents and relay this information to the team by utilizing a project management platform, Basecamp.
- Vitals, phlebotomy and laboratory. You will be responsible for collecting patient vitals, drawing labs, as well as processing and shipping samples.
- You have a minimum of 1 year clinical research experience, so you already know the basics. For example, you can rattle off these acronyms in your sleep: EDC, GCP, ICF, SIV/IMV/COV, AE/SAE, and DOA.
- You have experience reviewing patient charts in order to assess eligibility for enrolling trials. You're not afraid to pick up the phone to screen a patient for a new study and by the time you're done the two of you are BEST buds.
- How to effectively manage your time when there is a lot on your plate. You've got tried and true techniques to keep you on tasks, meeting your own deadlines, and setting yourself up for success.
- Previous experience in or passion for ophthalmology is a major plus!
- As the project manager of the studies you are assigned as lead, you will learn to execute timely study start-up, develop source documents, and manage monitoring visits.
- You will learn how to perform quality assurance checks and audit patient source and regulatory files.
- Regulatory tasks such as file maintenance, start-up document execution and collection, and IRB reporting guidelines.
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