Clinical Research Associate/ Sr.Clinical Research Associate -Milwaukee

Job description

Job Description

Support the goals of the GenMed organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Central point of communication between Novartis and investigational sites for all Oncology clinical trial related activities. Mentor to CRAs. Leader of internal Novartis CRA teams (local and global) when assigned
1. Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May represent RAD and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs. 2. Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification. 3. Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Degree in scientific or healthcare discipline. Master’s degree preferred English Prefer 2 to 4 years pharmaceutical industry experience including monitoring activities Excellent knowledge of the drug development process specifically clinical trials/research Knowledge and experience of international standards (GCP/ICH, FDA, EMEA)
Level will be commensurate with experience