- 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.
- 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
- 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.
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Senior Clinical Research Associate - Plainsboro, United States - System One Holdings, LLC
Description
Senior Clinical Research Associate - RegionalLocation: 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:
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.
