CRA Senior Clinical Research Associate

About the job

We are Growing! Let us support your career journey the Biorasi way. Innovative Collaborative Dynamic and Evolving. Capitalizing on your strengths while encouraging worklife balance. Biorasi is an awardwinning customerfocused fullservice clinical research organization.

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 fastpaced 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.

Your role:

• Schedule Plan and Conduct Site Visits: Site Selection Visits Site Initiation Visits Interim Monitoring Visits and Site Closeout Visits.
• Write Reports and Investigator Followup Letters for Site Visits: Site Selection Visits Site Initiation Visits Interim Monitoring Visits and Site Closeout Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals recruitment and enrolment 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 Protocol Deviations/Violations and Waivers review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation reviewing site performance providing feedback to CRAs and CTAs resolving issues performing review and oversight of site visit reports.
• May review protocols eCRFs study manuals and other study related documents as requested by the Clinical Trial Manager.
• May conduct onsite evaluation visits and onsite training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist as appropriate with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance trainings and professional growth.
• Other duties as assigned.

Your Profile:

• Bachelors 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.

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Remote Work :

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