Medix™
Clinical Research Coordinator - 235692
Medix™, Newport Beach, California, United States
Clinical Research Coordinator Great opportunity to work with a big name sponsor on an Ophthalmology study 100% ON SITE Position Summary: The candidate will be coordinating clinical research protocols from study start up to close out. This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices. Responsibilities: May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO Participates in the identification of potential clinical trial participants, screens them for eligibility, Coordinates the schedule of events for clinical trial participants from screening to follow up according to protocol Collects, verifies, organizes and records clinical information and data in electronic data capture systems (EDC). Abstracts data from necessary sources to complete the EDC and resolve queries. Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding May be responsible for regulatory submissions - Need working knowledge of essential documents and IRB requirements Participates in site feasibility determination, site qualification visits, site initiation visits and research related meetings May be responsible for recruiting clinical trials to site Resolve queries Important Details: Education/Experience Required: 1 years of experience as a CRC within the Ophthalmology space, if no experience with Ophthalmology then 3 years as a CRC is a MUST HAVE Schedule/Shift: 40 hours per week, Monday - Friday 8AM - 5PM Assignment Duration: 10 month contract; project wrap up estimated to be in September 2025 Benefits: Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances) Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).) 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1) Short Term Disability Insurance Term Life Insurance Plan Further Information: We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.