Your role:

• 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: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out 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 on-site evaluation visits and on-site 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:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and or other relevant clinical research experience.
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• 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).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at [email protected].