Senior Clinical Research Associate

October 28

Apply Now

Receive Emails with Similar Jobs

Biorasi

WebsiteLinkedInAll Job Openings

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

201 - 500

Description

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits • Write Reports and Investigator Follow-up Letters for Site Visits • Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution • Provide project updates to project management team • Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites • Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required • Assists with, prepare for, and attends Investigator Meetings for assigned studies • Review study documents for compliance with protocol, ICH GCP guidelines • Collect and review essential study documents from site for filing in eTMF • Administers protocol and related study training to assigned sites • Evaluates quality and integrity of study site practices • Follow international GCP guidelines/regulations and SOPs • Assists the Clinical Trial Manager with clinical operations activities • May review protocols, eCRFs, study manuals and other study related documents • May conduct on-site evaluation visits and on-site training of CRAs • Lead and partake in regular team meeting / teleconferences • Assist with reporting site performance regarding timelines and deliverables during project team meetings • May serve as mentor to associates

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