Responsibilities :
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom’s SOPs
- Execute assigned clinical trials including start up, subject recruitment & scheduling, consenting, screening, subject training, collection of regulatory documents, conducting study visits, performing SMBG testing, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports
- Responsible for identifying and escalating safety events and major protocol deviations
- Collaborate with project management to establish and maintain study timelines.
- Manage all clinical tasks and deliverables to meet clinical timeline
Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
- Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
- Coordinate preparation of key documents for trial site submission to IRBs.
- Assists management with departmental audits of clinical studies and procedures.
- Collaborate effectively with peers and leadership across departments and can professionally interact / build relationships with FDA, IRB, and key opinion leaders.
Requirements :
- Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience
- Must have an active Medical Certificate in the State of Arizona
- RN, LPN, LVN, CNA, EMT
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
- Knowledge of GCP (Good Clinical Practice)
Nice to have Skills :
- Certification as a clinical research associate or coordinator (, CCRA, CCRC)
- Monitoring clinical studies experience or experience as a study coordinator is a plus
- Clinical Trial Management System (CTMS) experience.
- Experience in continuous glucose monitoring (CGM) is a plus.
Benefits that Russell Tobin offers :
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
LI-LG1
Rate / Salary : $50-57 / hr
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