Clinical Research Coordinator

Job Title: Clinical Research Coordinator
Location: Rochester, NY (100% onsite)
Type: Contract
Compensation: $25/hr - $30/hr depending on level of experience
Contractor Work Model: Onsite – onsite
Hours: 40.0 hours per week
Security Clearance: Not specified

Overview
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Responsibilities

• Manage all aspects of a study ensuring adherence to the protocol, GCP, and applicable regulations, including participating in the informed consent process, coordinating, and performing all study visit procedures per protocol, managing Investigational Product and study related supplies and equipment, assisting with monitoring visits, attending Investigator Meetings, and assisting with query resolution, as required.
• Provide the highest level of care and excellent customer service for study participants.
• Collaborate with lab staff to plan for and manage laboratory samples throughout the length of the study, including review of the laboratory manual.
• Ensure study drug is dispensed, accounted for and returned to the Sponsor per protocol.
• Ensure Serious Adverse Events (SAE’s) are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) within 24 hours of site being notified of event, including collecting all required information for initial and follow-up reporting.
• Ensure visit logs and CTMS visit status are accurate and complete.
• Facilitate ongoing Quality Assurance (QA) review of studies, in collaboration with the QA department, including assisting with risk assessments, root cause analysis, and development of corrective and preventative actions as applicable.

Requirements

• 4-year degree in related field or NYS LPN License required, or related experience as a clinical trial coordinator.
• At least three years’ experience in clinical research setting.
• CCRC preferred
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced environment.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Salary : $25 - $30