Clinical Research Representative needed in Irvine – 10849424
****Immediate Need and Interview
1. Review and ensure accuracy and completeness of clinical study files (40%)
2. Organize documents and data in eTMF (electronic trial master file), CTMS (clinical trial management system) and ensure compliance with internal procedures. May review clinical data for completeness for multiple clinical research trials (40%)
3. Collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites (15%)
Candidate will start this assignment remote, my integrate back onsite based on Clients reintegration plans. Looking for local candidates.
1. Veeva Vault (eTMF) experience- 1 year
2. Minimum 1 year of work experience in related field (trial administrator, study start up, med device) required.
3. Looking for a seasoned clinical research coordinator/representative
4. Pharma/med device experience required
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast paced environment
• Substantial knowledge and understanding of Clients policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint and Outlook email rules.
• Good written and verbal communications skills
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Contacts are across the organization, and may include external contacts
Education and Experience: Required Bachelor's Degree in science or related field. Medical device experience preferred. Veeva Vault eTMF experience preferred. Minimum 1 year of work experience in related field (trial administrator, study start up, med device) required.
TechData Service Company LLC