Senior Clinical Research Associate

2 days ago

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Biorasi

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Contract Clinical Research • Complex Clinical Trials • Digital Therapeutics • Clinical Trial Rescue • Nephrology

201 - 500

Description

• Schedule, Plan and Conduct Site Visits • Write Reports and Investigator Follow-up Letters for Site Visits • Manages the progress of assigned studies • Provide project updates to project management team • Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials • Perform investigational product inventory • Assists with, prepare for, and attends Investigator Meetings • Review study documents for compliance with protocol • Collect and review essential study documents from site • Administers protocol and related study training • Evaluates quality and integrity of study site practices • Compliances with international GCP guidelines • Assists the Clinical Trial Manager with clinical operations activities • May review protocols, eCRFs, study manuals • May conduct on-site evaluation visits • Lead and partake in regular team meetings • Assist with reporting site performance during project team meetings • May serve as mentor to associates • Other duties as assigned

Requirements

• Bachelor’s Degree in biomedical sciences or related scientific discipline • Fluent English (oral and written) and applicable local business language • Minimum two to three years of monitoring experience, more experience would be preferred, along with combination of clinical research coordinator and or other relevant clinical research experience • Sound knowledge of medical terminologies and clinical monitoring process • Sound knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements • Excellent verbal, written communication, and presentation skills • Good leadership, planning, project management skills, verbal communication skills, and written communication skills • Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel) • Effective business skills for interactive situations with peers, sites, and clients

Benefits

• Half-day Fridays • Paid time off • Paid holidays • Extensive country specific benefits • Employee bonus programs • Career growth • Training and development