Perm In-House Clinical Research Associate I
One of our Sponsor partners is looking for a data driven Clinical Research Professional to become part of their close knit team. The ideal candidate is seeking a long-term growth opportunity with a collaborative, outstandingly dynamic team, working on an amazing product!
- Assist in study start up activities including collection and tracking of essential documentation needed for site initiation
- Ensures compliance with Sponsor SOPs, Study Protocol, GDP, GCP and Regulatory
Conduct periodic assessments of documents submitted to the eTMF and manage an assessment tracking tool throughout a study’s lifecycle.
- Maintain awareness of study events and associated documentation requirements through collaboration with functional/sub-functional area study team members.
- Effectively manage clinical study sites by building strong and collaborative relationships with Investigators and staff.
- Responsible for regularly reviewing site recruitment, ensuring timely implementation of contingency plans to ensure recruitment goals are met.
- Generate and assist in the closure of data queries and follow-up on safety issues and safety reports in a timely manner.
- Proactively identify, document, and assist in the resolution of issues relating to subject recruitment, study data quality, and study conduct at assigned study sites.
- Provide status of site activity via regular presentation to management
- This is an in-house position, so must live locally in the Lake County Ohio or Orange County California areas
- Being technologically savvy is required
- Must possess excellent communication skills
- Bachelor's Degree Required