What are the responsibilities and job description for the CRA position at ALKU?
Senior Clinical Research Associate(Hybrid Remote)
Background: The Sr. Clinical Research Associate/Specialist will assist the trial team with monitoring progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start-up, enrollment, follow up and closure of clinical trial activities.
Project:
- Supports management in the execution of operational aspects of clinical trials including, but not limited to data review, metrics generation, site and HCP compensation review & facilitation, core lab imaging tracking and reconciliation
- Proactively manages clinical data compliance, including data review and interpretation for early identification of trends
- Assists with trial documentation review and maintenance
- Communications: ensures clear written communication to clinical sites and project team members through general correspondence
- Training: ensures all sponsor and vendor trial team personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol
- Site Compliance: assists trial team with identification of non-compliance issues via generation of study metrics, and general study data reviews.
Required Skills:
- Therapeutic knowledge in peripheral intervention (PI)
- Minimum 5 years clinical research experience
- Can work collaboratively and demonstrates flexibility in work requests and prioritization
- Self-starter, ability to learn quickly, complete tasks timely with quality, and an independent contributor
****The ideal candidate must live within an hour driving distance of Maple Grove, MN!***
