Senior Clinical Research Associate

7 days ago

Plainsboro, New Jersey, United States System One Holdings, LLC Full time
Senior Clinical Research Associate - Regional
Location: Home Based, Philadelphia, PA Area

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 supporting Endocrinology studies, 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.

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