What are the responsibilities and job description for the Senior Clinical Research Associate position at System One Holdings, LLC?
Senior Clinical Research Associate - Regional
Location : Home Based, Dallas, TX
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 :
Working Conditions :
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.
