Clinical Research Associate (CRA) - B
1360-1380 South Loop Road Alameda, CA 94502 US
Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.
Bachelor’s degree REQUIRED WITH A PREFERANCE IN Biological Sciences which fit best BUT “Life Sciences” degrees will also be considered
• Minimum of 3 to 5 years of clinical exp. within industry
• Specifically looking for monitoring exp. on the sponsor side
• Will be supporting a multi-site study
• Exp. with site selection
• Will be doing monitoring visits
• Medical device exp. of at least 1 year
• Exp. coordinating site initialization and site close
• Familiar with IRB (Institution Review Board) submission
• ICF (informed consent forms) revision exp.
• Exp. editing/revising CRF “case report forms”
• Familiarity with data cleaning and database process (Queries)
• Basic MS Office with Outlook, Project, PowerPoint and Excel
• Training PI staff
• HCI Guidelines
• “Viva” exp. is for electronic filing is preferred
• Device Trial Study where will be tracking adverse events
• Take ownership and coordinate shipping out devices, the return of devices and device accountability
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.