Senior Clinical Research Associate

Senior Clinical Research Associate - Regional

Location: Home Based, Miami FL

Type: Full time

Start Date: ASAP

Are you an experienced Clinical Research Associate that's looking for lower, regional travel and a good work/life balance? Do you value a healthy, and engaging work environment?

This is an excellent opportunity to check off all of the above!

You are working for a sponsor, in a therapeutically aligned model conducting remote and onsite monitoring of regional sites in a risk-based monitoring model.

Responsibilities

• Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout.
• Ensure collection of high-quality data, timely adverse event reporting, subject protection, and compliance to the protocol.
• Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met.
• Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones.
• Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing.
• Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.
• Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines.
  
  

Requirements

• Educational requirement: BA/BS
• Years of experience: 3 years of CRA (monitoring experience)
• Industry experience: 5 years of clinical research industry experience
• Diabetes experience is a nice to have
• Remote Monitoring Experience
• Risk Based Monitoring
  
  

Working Conditions

• Works from a home office environment at least one day a week.
• Works at hospitals, medical clinics three to four times a week.
• May be required to drive, fly, or take train to location to perform duties of the job.
• Up to 70% travel required.
  
  

Benefits

System One offers 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.

Ref: #568-Clinical