Senior Clinical Research Associate

Company: Joul--
Location: Dallas
Posted on: February 3, 2025

Job Description:

Senior Clinical Research Associate - Regional

Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
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: 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.

Keywords: Joul--, North Richland Hills , Senior Clinical Research Associate, Healthcare , Dallas, Texas