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 : 20 hours per week, Flexibility on days worked but must be during weekdays (Monday - Friday)
- Assignment Duration : 6 month contract with possible extension to 12 months in duration
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
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