Sr. Clinical Research Representative - OQSIE
Irvine, CA 92614
About the Job
| Responsible for efficient processing and quality check of all study documents. | |||
| Skills: | Responsible for efficient processing and quality check of all study documents. Key Responsibilities: • Support and organize the preparation of Clinical Study binders • Supervision of clinical study applications/submissions to Ethical Committees and Competent Authorities as an administrative support function to the Study Managers; • Support the Study Managers upon request from study managers based on project needs; • Responsible for all document archiving; • Control document validity and compliance (i.e. insurance certificates, etc.); • Organization of meetings related to clinical investigations such as Clinical Event Committees, Data Safety Monitoring Boards, Executive Committees and Steering Committees; • CTMS support • Support clinical department on all business needs • Organize and document (paper and LMS) together with Clinical Managers/Directors employees trainings and all internal meetings; • Manage all administrative aspects related to the Clinical Programs Europe THV in term of clinical study cost accountability; • Conduct payment overviews (cost lists and invoices) and issue payments upon request • Conduct periodic audits of documentation and may participate in internal master file audits • Provide coaching and training to lower level employees • Interact with clinical sites to resolve more complex device accountability issues • Provide training and technical support for internal and external users and set-up of new users in Wavemark • Strict attention to detail • Ability to interact professionally with all organizational levels | ||
| Education: | Education and Experience: H.S. Diploma or equivalent 6 years experience previous related experience Required Additional Skills: • Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery • Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred • Excellent written and verbal communication skills and interpersonal relationship skills • Ability to work in a fast paced environment • Demonstrated problem-solving and critical thinking skills Note: This monitoring position will have up to 20 sites and 4 small scale studies and will travel West to MidWest. Must be near a HUB airport such as Detroit Colorado, Dallas, Minneapolis etc. | ||
Source : OQSIE