ClinDatrix is looking to hire full time regional CRA employees for the following regions: West Coast, East Coast, and Mid-West. For the West Coast region, candidate should be located in CA, ideally in Southern CA. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities
• Responsibilities primarily involve management of assigned investigational study sites including: prestudy, initiation, monitoring and study close-out site visits.
• Generate, revise, circulate and/or track project-specific documentation as needed including but not limited to protocol, case report forms and completion guidelines, informed consent forms, and regulatory packets.
• Contribute to maintenance of Trial Master File and electronic project organization and documentation system.
• Maintain contact with study sites, sponsor, and other involved parties to ensure good communication and progress of project.
• Organize and/or participate in training exercises as needed to remain as current as possible in related areas.
• Assist with writing, revising, and participate in training and presentations of industry Standard Operating Procedures
Qualification and Requirements
• Bachelor’s degree or the equivalent in a scientific discipline
• Three or more years of work experience with clinical site monitoring experience
• Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management, and regulatory compliance
• Excellent accuracy and attentiveness to detail
• Strong written and verbal communication skills; strong interpersonal skills
• Good organizational skills with ability to multitask and prioritize workload
• Good computer skills (Word, Excel, Email)
• Effectively work independently as well as within a team matrix
• Willing and able to travel
• Ability to handle stressful situations and deadlines
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