.We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you've ever heard of. Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients.Here is your chance to become a vital part of a growing global company in the expanding clinical research industry. Start your career journey at Biorasi today with our newest opportunity - Senior Clinical Research Associate (CRA)! This is a remote based position located anywhere within Spain.Overview- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.- Development and work-life balance: We want our employees to develop personally as well as professionally.Your ResponsibilitiesSchedule, 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: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.Manage the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission.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.Assist with, prepare for, and attend Investigator Meetings.Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers.Collect and review essential study documents from site for filing in eTMF.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.Evaluate quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.Follow international GCP guidelines/regulations and SOPs for executing clinical studies.Assist the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs.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 meetings
