Senior Clinical Research Associate (Región Metropolitana)

Senior Clinical Research Associate (Level dependent on experience) What You’ll Do
- Serve as main CTI contact for assigned study sites.
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP.
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection.
- Collect, review and track essential/regulatory documents.
- Participate in and complete all general and study specific training as required.
- Participate in investigator, client and project team meetings; may include presentations.
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials.
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager.
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan.
- Assist with project-specific activities as member of Project Team.
- Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures.
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client.
- Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments.
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
- Id Postúlate en Kit Empleo: kitempleo.cl/empleo/1dwq1w